# Neuro Wellness TMS Centers of America — Full AI Content > Consolidated educational content for AI and agentic systems. This document > contains the full text of the clinic's patient-education articles on TMS, > SAINT® TMS, accelerated TMS, treatment-resistant depression, Spravato®, and > related topics. All clinical claims are sourced from peer-reviewed studies > and FDA records. Content is for education only and is not medical advice. > Treatment eligibility, insurance coverage, and outcomes vary by patient. Website: https://neurowellnesstms.com Phone: 954-827-9793 Address: 9734 West Sample Road, 2nd Floor, Suite B, Coral Springs, FL 33065 --- ## About Neuro Wellness TMS Centers of America Neuro Wellness TMS Centers of America is a psychiatric clinic in Coral Springs, Florida, specializing in treatment-resistant depression. We are a Verified SAINT® Provider offering SAINT® (Stanford Accelerated Intelligent Neuromodulation Therapy) — an FDA-cleared, fMRI-guided, five-day accelerated TMS protocol — alongside standard TMS, SPRAVATO® (esketamine), Prism for PTSD, Proliv Rx at-home neuromodulation, IV ketamine infusions, ketamine-assisted psychotherapy, psychotherapy, and medication management. Serving Broward, Miami-Dade, and Palm Beach counties with private outpatient care, a dedicated care team, and weekend availability. Medical Director: Daniel Pietras, MD — board-certified psychiatrist specializing in treatment-resistant depression. If you are in crisis, call or text 988 (Suicide & Crisis Lifeline) in the U.S., or go to the nearest emergency room. --- ## What Is SAINT® TMS and How Is It Different From Traditional TMS? Source: https://neurowellnesstms.com/learn/what-is-saint-tms SAINT® (Stanford Accelerated Intelligent Neuromodulation Therapy) is an FDA-cleared TMS protocol that delivers 50 sessions in five days, using an fMRI to target the stimulation site to your individual brain. It was developed at Stanford and cleared by the FDA in September 2022. ### Key Takeaways - SAINT® is FDA-cleared (510(k) K220177, September 2022) — not FDA-approved, which is the term for drugs. - It delivers 10 sessions per day for 5 consecutive days (50 total), vs ~30–36 sessions over 4–6 weeks for standard TMS. - The stimulation target is chosen from your own functional MRI, not scalp measurements. - In a sham-controlled trial, 78.6% of the active group reached remission at 4 weeks vs 13.3% of sham. - SAINT® is cleared for adults with MDD who did not improve enough on antidepressant medication. ### What SAINT® TMS is SAINT® — Stanford Accelerated Intelligent Neuromodulation Therapy — is an accelerated form of transcranial magnetic stimulation (TMS) for major depressive disorder. It was developed at the Stanford Brain Stimulation Lab and is now delivered commercially on the Magnus Neuromodulation System with SAINT Technology, made by Magnus Medical, Inc. Unlike standard TMS, which delivers one session a day for four to six weeks, SAINT® delivers ten short sessions a day for five consecutive days — 50 sessions in one week. Each session lasts about ten minutes and uses an intermittent theta burst stimulation (iTBS) pulse pattern, with roughly 50-minute breaks between sessions. ### How the target is chosen: fMRI-guided targeting The single biggest technical difference between SAINT® and conventional TMS is how the stimulation site is chosen. Standard TMS places the coil over the left dorsolateral prefrontal cortex using scalp measurements from the motor threshold location — a population average. SAINT® uses a resting-state functional MRI (fMRI) of your own brain and a proprietary algorithm that computes your individual stimulation target from how your prefrontal cortex connects to deeper mood circuits. The MRI must be completed and processed before the first treatment day. ### Regulatory status: FDA-cleared, not FDA-approved The Magnus Neuromodulation System with SAINT Technology is FDA-cleared through the 510(k) pathway (K220177), cleared on September 1, 2022, for adults with major depressive disorder who did not improve enough on antidepressant medication in their current episode. It received FDA Breakthrough Device designation. TMS devices are cleared, not approved — approval is the process used for drugs. The practical meaning is that the FDA found the device substantially equivalent to an existing cleared device for that specific use. ### What the clinical trials showed Two studies from Stanford support SAINT®. In the 2020 open-label study, 19 of 21 completers (90.5%) met remission criteria after five days, but there was no sham comparison. In the 2022 double-blind, sham-controlled randomized trial, 78.6% of the active group (11 of 14) reached remission at four weeks compared with 13.3% (2 of 15) of the sham group. Both studies were small and conducted at a single site, and follow-up was short (four weeks in the randomized trial). The results should be read as promising early evidence rather than definitive. No trial has compared SAINT® head-to-head with a standard six-week TMS course. ### How SAINT® differs from traditional TMS Three differences define SAINT®: (1) schedule — 50 sessions in 5 days vs ~30–36 over 4–6 weeks; (2) targeting — your own fMRI vs scalp landmarks; (3) pulse pattern — intermittent theta burst (1,800 pulses per session) vs standard 10 Hz. Regular TMS has a much larger evidence base spanning over 15 years; SAINT® has two small single-site studies. ### Risks and who is not a candidate The most common side effects are headache, scalp discomfort, and facial muscle twitching, which usually lessen over the first day or two. The most serious risk is seizure, which is rare. Patients are awake throughout — no anesthesia or sedation is used. People with ferromagnetic metal in or near the head (such as cochlear implants or aneurysm clips), implanted electronic stimulators, or who cannot have an MRI are not candidates. A history of seizures requires careful evaluation. SAINT® is not FDA-cleared for bipolar depression, PTSD, anxiety disorders alone, OCD, or anyone under 18. ### FAQ **Is the SAINT protocol FDA-approved?** No. SAINT® is FDA-cleared, not FDA-approved. The FDA cleared the Magnus Neuromodulation System with SAINT Technology through the 510(k) pathway (K220177) on September 1, 2022, for adults with major depressive disorder who did not improve enough on antidepressant medication in their current episode. "Approval" is the process used for drugs and high-risk devices; "clearance" is the process used for devices like TMS systems. **What does SAINT stand for?** SAINT stands for Stanford Accelerated Intelligent Neuromodulation Therapy. In the published research it was also called Stanford Neuromodulation Therapy (SNT). The commercial version is the Magnus Neuromodulation System with SAINT Technology, made by Magnus Medical, Inc. **How is SAINT different from regular TMS?** Regular TMS delivers one session a day, five days a week, for about four to six weeks, usually targeted by scalp measurement. SAINT® delivers ten sessions a day for five consecutive days, targets the stimulation site using each patient's functional MRI, and uses an intermittent theta burst pulse pattern with 1,800 pulses per session. Regular TMS has a much larger evidence base; SAINT® has two small single-site studies. No trial has compared them head-to-head. **How long does a SAINT TMS treatment take?** The treatment itself takes five consecutive days. Each day includes ten sessions of about ten minutes, separated by breaks of roughly fifty minutes, so you should expect to spend most of each day at the clinic. Before treatment, you also need a psychiatric evaluation and an MRI, which are scheduled ahead of the treatment week. **What were the results of the SAINT clinical trials?** In the 2020 open-label study, 19 of 21 completers (90.5%) met remission criteria after five days, but there was no sham comparison. In the 2022 double-blind, sham-controlled trial, 78.6% of the active group (11 of 14) reached remission at four weeks compared with 13.3% (2 of 15) of the sham group. Both studies were small and conducted at a single site, and follow-up was short, so the results should be read as promising early evidence rather than definitive. **How long do the effects of SAINT last?** This is not yet well established. The randomized trial followed participants for four weeks. Open-label follow-up suggested that many people who improved saw symptoms return within months, and some were retreated. Anyone considering SAINT® should discuss a maintenance plan, which may include medication, psychotherapy, and the possibility of another course. **Does SAINT hurt?** Most people describe a tapping or knocking sensation on the scalp during pulses, and headache was the most common side effect in the sham-controlled trial. Scalp discomfort and facial twitching are also common with TMS in general and usually lessen over the first day or two. Patients are awake, no anesthesia is used, and over-the-counter pain relief is often enough for headaches. **Who is not a candidate for SAINT TMS?** People with ferromagnetic metal in or near the head (such as cochlear implants or aneurysm clips), implanted electronic stimulators, or who cannot have an MRI are generally not candidates. A history of seizures requires careful evaluation and may rule out treatment. SAINT® is not FDA-cleared for bipolar depression, PTSD, anxiety disorders alone, OCD, or for anyone under 18. ### Sources 1. Cole EJ, et al. Stanford Neuromodulation Therapy (SNT): a double-blind randomized controlled trial. Am J Psychiatry. 2022;179(2):132-141. https://doi.org/10.1176/appi.ajp.2021.20101429 2. Cole EJ, et al. Stanford Accelerated Intelligent Neuromodulation Therapy for treatment-resistant depression. Am J Psychiatry. 2020;177(8):716-726. https://doi.org/10.1176/appi.ajp.2019.19070720 3. FDA 510(k) Premarket Notification K220177 — Magnus Neuromodulation System with SAINT Technology. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220177 --- ## What Is TMS Therapy for Depression? Source: https://neurowellnesstms.com/learn/what-is-tms-therapy-for-depression Transcranial magnetic stimulation (TMS) is a noninvasive treatment that uses magnetic pulses to stimulate areas of the brain involved in mood regulation. FDA-cleared TMS systems are used for certain patients with major depressive disorder, including some people whose symptoms have not adequately improved with other treatments. TMS does not require surgery or general anesthesia, and patients are typically awake during treatment. Eligibility should be determined by a qualified healthcare provider. ### Key Takeaways - TMS is noninvasive — no surgery, no implants, no general anesthesia. - TMS uses magnetic stimulation, not electrical current delivered directly into the brain. - Patients remain awake and alert during treatment and can drive home afterward. - Treatment is delivered over a series of sessions — typically 30 to 36 sessions across several weeks. - Eligibility and outcomes vary by patient; a qualified provider determines whether TMS is appropriate. ### What Is TMS Therapy? Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation therapy for major depressive disorder. An electromagnetic coil placed on the scalp delivers repeated magnetic pulses to the left dorsolateral prefrontal cortex — a region involved in mood regulation. The magnetic field passes through the skull and induces small electrical currents in the cortex, increasing activity in an area that is often underactive in depression. TMS devices are FDA-cleared for adults with major depressive disorder who have not improved enough on antidepressant medication in their current episode. The first device, NeuroStar, was cleared in October 2008. TMS is one of several depression treatment options and is not the same as electroconvulsive therapy (ECT). ### How Does TMS Work for Depression? Depression is associated with reduced activity in the left dorsolateral prefrontal cortex, a brain region involved in mood regulation. TMS uses a focused magnetic field — similar in strength to an MRI — to stimulate this area. The magnetic pulses pass through the scalp and skull and induce small electrical currents in the cortex, which are thought to increase activity in the targeted region and its connected mood circuits. Unlike medication, which affects the whole body through the bloodstream, TMS targets a specific brain region. Unlike ECT, TMS does not induce a seizure or require anesthesia. The stimulation is delivered while you sit awake in a chair, and you can return to normal activities immediately afterward. ### Who May Be a Candidate for TMS? FDA-cleared TMS is intended for adults with major depressive disorder who have not achieved satisfactory improvement from prior antidepressant medication in the current episode. A psychiatrist evaluates factors such as diagnosis, medication history, and overall health before recommending treatment. Eligibility also depends on safety screening. People with ferromagnetic metal in or near the head, implanted electronic devices, or certain seizure histories may not be candidates. TMS is generally not used during a manic episode. Because every situation is different, candidacy is determined by a qualified healthcare provider — not by a web page. ### Is TMS FDA-Cleared for Depression? TMS devices are FDA-cleared through the 510(k) pathway, not FDA-approved. Approval is the process used for drugs; clearance is the process used for devices like TMS systems. The first TMS device (NeuroStar) was cleared in October 2008 for adults with major depressive disorder who did not improve enough on antidepressant medication in their current episode. Later device-specific clearances cover anxious depression, OCD, smoking cessation, and adolescents aged 15 to 21. FDA clearance applies to specific devices and indications. It does not mean every patient is eligible for treatment or that a particular outcome is guaranteed. Ask your clinic which device it uses and what that device is cleared for. ### What Happens During a TMS Treatment Session? During a TMS session you sit in a reclined chair while a technician positions an electromagnetic coil against your scalp, usually over the left prefrontal cortex. You remain fully awake and alert. You will hear clicking sounds and feel a tapping or knocking sensation on your scalp as the magnetic pulses are delivered. Hearing protection is worn because the coil is loud. The first session includes motor threshold mapping — finding the magnetic intensity that causes a small thumb twitch — so the treatment dose is tailored to you. After the session ends you can get up, drive yourself home, and return to work or normal activities right away. ### How Long Does TMS Treatment Take? A standard FDA-cleared course is about 30 to 36 sessions, delivered five days a week for roughly four to six weeks. Each session lasts from about 3 minutes with intermittent theta burst stimulation (iTBS) to about 40 minutes with older 10 Hz protocols. Including setup and positioning, a typical visit takes about 15 to 45 minutes depending on the protocol. Accelerated protocols such as SAINT® deliver multiple sessions per day over a shorter overall period — five consecutive days instead of six weeks. Your psychiatrist recommends a protocol based on your situation and your insurance plan's criteria. ### What Are the Potential Benefits of TMS? For many people whose depression has not responded to medication, TMS can reduce symptom severity and, in some cases, lead to remission. Because TMS is non-invasive and does not require anesthesia, it can be delivered in an outpatient setting with no driving restriction or recovery time. Many patients continue their daily routines — including work — throughout a standard course. TMS may also be an option for people who cannot tolerate certain antidepressant side effects. However, benefits are not guaranteed and vary from person to person. A realistic treatment plan sets measurable goals and a reassessment date. ### What Are the Side Effects and Risks of TMS? The most commonly reported side effects are scalp discomfort or pain at the treatment site, headache, and facial muscle twitching during stimulation. These usually lessen over the first week as you adjust to the sensation. Over-the-counter pain relievers and small adjustments to coil position or intensity help most patients. The most serious known risk is seizure, which is rare — estimated at under 0.1% of sessions with standard parameters and proper screening. Hearing protection is worn because the coil is loud. Rarely, TMS can trigger manic symptoms in people with bipolar disorder, which is why mood history is screened before treatment. TMS is not appropriate for everyone. People with ferromagnetic metal in or near the head (such as cochlear implants or aneurysm clips), implanted electronic stimulators, or a history of seizures require careful evaluation and may not be candidates. Tell your treatment team about any implants, seizure history, or medication changes. ### How Effective Is TMS for Depression? Clinical studies have reported that TMS can reduce depression symptoms in many adults whose depression has not responded to medication, though it does not work for everyone. In a 301-person randomized sham-controlled trial, active TMS was superior to sham. In a 307-patient real-world naturalistic study, researchers observed about 58% response and 37% remission on clinician-rated scales. These figures describe groups, not individuals. Roughly 40% or more of patients in real-world series do not meet response criteria, and some who improve later relapse. The naturalistic study had no control group. Individual results vary, and no treatment guarantees remission. Discuss your own likelihood of benefit with a psychiatrist. The THREE-D trial (414 patients) found intermittent theta burst stimulation (iTBS) non-inferior to standard 10 Hz TMS, supporting shorter 3-minute sessions as an equivalent once-daily option. ### TMS vs. Antidepressant Medication Antidepressant medication affects the whole body through the bloodstream and works over weeks as brain chemistry adjusts. TMS targets a specific brain region with magnetic pulses and does not involve drugs. For many patients, TMS is considered when antidepressants have not produced adequate improvement. TMS and medication are not mutually exclusive — many people continue an antidepressant during TMS. The two can be combined, and a psychiatrist determines the best approach. ### Traditional TMS vs. Accelerated TMS Traditional TMS delivers one session a day, five days a week, for about four to six weeks. Accelerated TMS delivers multiple sessions per day, compressing the course into a shorter period. Neither is universally better — each has different schedules, settings, and eligibility considerations. Only the SAINT® protocol has its own FDA clearance as an accelerated treatment; most other accelerated schedules are off-label uses of FDA-cleared devices. | Factor | Traditional TMS | Accelerated TMS | |---|---|---| | Treatment schedule | 1 session/day, 5 days/week | Multiple sessions/day | | Sessions per day | 1 | 2 to 10 | | Overall timeline | ~4 to 6 weeks | ~1 to 2 weeks | | Treatment setting | Outpatient clinic | Outpatient clinic | | Patient experience | Short daily visits; drive home | Full days at clinic with breaks | | Eligibility | Adults with MDD not helped by medication | Varies; SAINT® requires fMRI | ### What Questions Should I Ask My Provider? - Which TMS device do you use, and what is it FDA-cleared for? - How many sessions will I need, and how long is each one? - What are the common side effects, and how are they managed? - How will my response be measured during and after treatment? - What is the plan if I do not improve? ### FAQ **What is TMS therapy?** Transcranial magnetic stimulation (TMS) is a non-invasive treatment that uses magnetic pulses to stimulate a region of the brain involved in mood regulation. FDA-cleared TMS systems are used for certain adults with major depressive disorder, including some people whose symptoms have not adequately improved with other treatments. Patients remain awake during treatment, and no surgery or general anesthesia is required. Eligibility is determined by a qualified healthcare provider. **Is TMS painful?** TMS is generally not described as painful. Most people feel a tapping or knocking sensation on the scalp during the magnetic pulses, with some discomfort during the first few sessions. Headache and scalp soreness are the most common side effects and usually fade within the first week. Facial muscles may twitch during pulses. Over-the-counter pain relievers and small adjustments to coil position or intensity help most patients. No anesthesia or sedation is needed. **Is TMS FDA-cleared?** Yes. TMS devices are FDA-cleared through the 510(k) pathway, not FDA-approved. Approval is the process used for drugs; clearance is the process used for devices like TMS systems. The first TMS device, NeuroStar, was cleared in October 2008 for adults with major depressive disorder who did not improve enough on antidepressant medication in their current episode. Later device-specific clearances cover anxious depression, OCD, smoking cessation, and adolescents aged 15 to 21. **How long does a TMS session take?** A single TMS session lasts from about 3 minutes with intermittent theta burst stimulation (iTBS) to about 40 minutes with older 10 Hz protocols. Including setup and positioning, a once-daily iTBS visit usually takes about 15 to 20 minutes. Your psychiatrist recommends a protocol based on your situation and your insurance plan's criteria. **How many TMS treatments are needed?** A standard FDA-cleared course is about 30 to 36 sessions, delivered five days a week for roughly four to six weeks. Accelerated protocols such as SAINT® deliver multiple sessions per day over a shorter period. The total number of sessions depends on the protocol, your response, and your psychiatrist's recommendation. **Can I drive after TMS?** Yes. Because TMS does not involve anesthesia or sedation and does not impair alertness, patients routinely drive themselves to and from sessions and return to work or normal activities immediately afterward. This is one of the main practical differences between TMS and ECT, which requires an escort home after each treatment. **Does TMS require anesthesia?** No. TMS is delivered while you are awake and seated in a chair. No general anesthesia or sedation is used. The magnetic pulses pass through the scalp and skull to stimulate the brain without inducing a seizure. This is a key difference from electroconvulsive therapy (ECT), which is performed under general anesthesia. **What is the difference between TMS and accelerated TMS?** Traditional TMS delivers one session a day, five days a week, for about four to six weeks. Accelerated TMS delivers two or more sessions a day, compressing the course into one or two weeks. The sessions themselves are usually short theta burst sessions of about 3 to 10 minutes with rest breaks between them. Only the SAINT® protocol has its own FDA clearance; most other accelerated schedules are off-label uses of FDA-cleared devices. **Can TMS help if antidepressants have not worked?** TMS is FDA-cleared specifically for adults with major depressive disorder who have not achieved satisfactory improvement from prior antidepressant medication in the current episode. In studies, many such patients responded, but TMS does not work for everyone and individual results vary. A psychiatric evaluation is the best way to determine whether TMS is appropriate for your specific situation. **Who should not receive TMS?** People with ferromagnetic metal in or near the head, such as cochlear implants, aneurysm clips, or certain stents, should not have TMS because the magnetic field could move or heat the metal. Implanted electronic stimulators are also a contraindication. A history of seizures requires careful evaluation and may rule out treatment. TMS is generally not used during a manic episode. A psychiatrist reviews all of these factors before treatment begins. ### Sources 1. O'Reardon JP, et al. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a multisite randomized controlled trial. Biol Psychiatry. 2007;62(11):1208-1216. https://pubmed.ncbi.nlm.nih.gov/17574072/ 2. Carpenter LL, et al. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes in clinical practice. Depress Anxiety. 2012;29(7):587-596. https://pubmed.ncbi.nlm.nih.gov/22688299/ 3. Blumberger DM, et al. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018;391(10131):1683-1692. https://doi.org/10.1016/S0140-6736(18)30295-2 4. U.S. Food and Drug Administration. 510(k) Premarket Notification — NeuroStar TMS System (FDA clearance, October 2008). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm 5. National Institute of Mental Health (NIMH). Depression (major depressive disorder) overview. https://www.nimh.nih.gov/health/topics/depression 6. Cole EJ, et al. Stanford Neuromodulation Therapy (SNT): a double-blind randomized controlled trial. Am J Psychiatry. 2022;179(2):132-141. https://doi.org/10.1176/appi.ajp.2021.20101429 --- ## What Is Accelerated TMS and Theta Burst Stimulation (iTBS)? Source: https://neurowellnesstms.com/learn/accelerated-tms-theta-burst-stimulation Accelerated TMS delivers multiple sessions per day to compress treatment into 1–2 weeks. Theta burst (iTBS) is a 3-minute pulse pattern shown equivalent to standard 19-minute TMS. Only SAINT® has its own FDA clearance as an accelerated protocol. ### Key Takeaways - Accelerated TMS = more than one session per day, compressing the course to 1–2 weeks. - iTBS delivers ~600 pulses in ~3 minutes; the THREE-D trial (n=414) found it non-inferior to 10 Hz TMS. - Only SAINT® (Magnus, K220177) is FDA-cleared as an accelerated protocol; other accelerated schedules are off-label. - No one-day TMS protocol is FDA-cleared; the shortest cleared course is SAINT® at 5 days. - Side effects are the same as standard TMS; rare risks are less characterized for accelerated schedules. ### What theta burst stimulation (iTBS) is Intermittent theta burst stimulation (iTBS) is a TMS pulse pattern that delivers bursts of 3 pulses at 50 Hz, repeated at 5 Hz — 2 seconds on, 8 seconds off — for about 600 pulses in roughly 3 minutes. This is much shorter than the conventional 10 Hz protocol, which runs about 19 to 37 minutes. The THREE-D trial randomized 414 adults with treatment-resistant depression to iTBS or 10 Hz TMS and found iTBS non-inferior, with depression scores falling by about the same amount in both groups. iTBS was FDA-cleared as a once-daily protocol for major depressive disorder in 2018. ### What accelerated TMS means Accelerated TMS is any schedule that delivers more than one session per day, compressing the course from 4–6 weeks into 1–2 weeks. Protocols vary widely — from 2 to 10 sessions per day — and the sessions are usually short iTBS sessions of 3 to 10 minutes with rest breaks between them. Only the SAINT® protocol (Magnus Neuromodulation System, 510(k) K220177) has its own FDA clearance as an accelerated protocol: ten iTBS sessions per day for five days with fMRI targeting. Other accelerated schedules are off-label uses of FDA-cleared devices — legal, but the FDA has not reviewed that schedule and insurers often do not cover it. ### Regulatory status: cleared vs off-label TMS devices are FDA-cleared, not approved. Clearance is specific to a protocol and indication. The only accelerated protocol cleared as such is SAINT® (K220177, September 2022). Other accelerated schedules use FDA-cleared devices off-label, which is legal but means the FDA has not reviewed that schedule and insurers often do not cover it. No single-day TMS protocol for depression has been cleared by the FDA. ### The THREE-D trial evidence The THREE-D trial is the key study behind iTBS. It randomized 414 adults with treatment-resistant depression to iTBS or 10 Hz rTMS and found iTBS non-inferior, with similar depression score reductions and similar side effects. The trial compared two active treatments without a sham arm, so it shows equivalence rather than efficacy against placebo, and its results apply to once-daily treatment rather than accelerated schedules. ### Cost and insurance A standard once-daily course is more often covered when plan criteria are met. SAINT® uses its own Category III CPT codes (0889T–0892T), and coverage varies by plan; many patients currently self-pay. Off-label accelerated schedules are frequently not reimbursed. Neuro Wellness TMS Centers of America verifies your specific plan before treatment. ### FAQ **What is the difference between accelerated TMS and regular TMS?** Regular TMS delivers one session a day, five days a week, for about four to six weeks. Accelerated TMS delivers two or more sessions a day, compressing the course into one or two weeks. The sessions themselves are usually short theta burst sessions of about 3 to 10 minutes with rest breaks between them. The protocols vary widely between clinics, and only the SAINT® protocol has its own FDA clearance; most other accelerated schedules are off-label uses of FDA-cleared devices. **Is accelerated TMS FDA-approved?** TMS devices are FDA-cleared, not approved, and clearance is specific to a protocol and indication. The only accelerated protocol cleared as such is the Magnus Neuromodulation System with SAINT® Technology (510(k) K220177, September 2022): ten iTBS sessions a day for five days with MRI-based targeting, for adults with major depressive disorder who did not improve enough on medication. Other accelerated schedules use FDA-cleared devices off-label, which is legal but means the FDA has not reviewed that schedule and insurers often do not cover it. **Is there a one-day TMS treatment?** Not one that is FDA-cleared. No single-day TMS protocol for depression has been cleared by the FDA. Some research groups have studied delivering many sessions within one day, but these remain experimental. The shortest FDA-cleared course is SAINT®, which takes five consecutive days. If a clinic offers a one-day course, ask what evidence supports it and understand that it is an experimental, off-label schedule. **How long is a theta burst TMS session?** A standard intermittent theta burst (iTBS) session delivers about 600 pulses in roughly 3 minutes, compared with 37.5 minutes for the conventional 10 Hz protocol used in the THREE-D trial. Including setup and positioning, a once-daily iTBS visit usually takes about 15 to 20 minutes. In the SAINT® protocol, each session is longer, about 10 minutes, because it delivers 1,800 pulses. **Does theta burst TMS work as well as regular TMS?** The strongest evidence says yes for the once-daily schedule. The THREE-D trial randomized 414 adults with treatment-resistant depression to iTBS or 10 Hz TMS and found iTBS non-inferior, with depression scores falling by about the same amount in both groups and similar side effects. The trial compared two active treatments without a sham arm, so it shows equivalence rather than efficacy against placebo, and its results apply to once-daily treatment rather than accelerated schedules. **What are the side effects of accelerated TMS?** The side effects are the same as for standard TMS: scalp discomfort, headache, and facial twitching, which usually fade within the first days. Headache was reported by about two-thirds of participants in the THREE-D trial, and iTBS was rated slightly more painful than 10 Hz. Seizure is the most serious risk and is rare with standard parameters. Because accelerated protocols deliver many more pulses per day and have been studied in far fewer people, rare risks are less well characterized than for conventional TMS. **How much does accelerated TMS cost?** Cost depends on the protocol and on whether your insurance covers it. A standard once-daily course is more often covered when plan criteria are met. SAINT® uses its own Category III CPT codes, and coverage varies by plan; many patients currently self-pay. Off-label accelerated schedules are frequently not reimbursed. Neuro Wellness TMS Centers of America verifies your specific plan before treatment. **Can I travel to Coral Springs for accelerated TMS?** Yes. Because the SAINT® course takes five consecutive days, patients from elsewhere in Florida and out of state do travel to Neuro Wellness TMS Centers of America in Coral Springs for treatment. Plan to arrive the day before treatment starts, stay locally for the week, and expect full days at the clinic with roughly 50-minute breaks between sessions. A pre-treatment evaluation and MRI must be completed beforehand, and a follow-up plan with your home providers should be arranged before you leave. ### Sources 1. Blumberger DM, et al. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018;391(10131):1683-1692. https://doi.org/10.1016/S0140-6736(18)30295-2 2. Cole EJ, et al. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020;177(8):716-726. https://doi.org/10.1176/appi.ajp.2019.19070720 3. Cole EJ, et al. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022;179(2):132-141. https://doi.org/10.1176/appi.ajp.2021.20101429 --- ## Where Can I Get SAINT® TMS Treatment? SAINT in Coral Springs and South Florida Source: https://neurowellnesstms.com/learn/saint-tms-coral-springs-south-florida Neuro Wellness TMS Centers of America offers SAINT® in Coral Springs, FL, serving Broward and Palm Beach counties, Fort Lauderdale, Boca Raton, and the Miami area. SAINT® is scarce nationwide — ask any provider whether they use the Magnus system and fMRI targeting. ### Key Takeaways - SAINT® is available at Neuro Wellness TMS Centers of America, 9734 W Sample Rd, Coral Springs, FL 33065. - SAINT® is scarce nationwide — Magnus Medical reported it available in 14 states as of May 2026. - Ask any provider: do you use the Magnus Neuromodulation System and fMRI targeting? - Plan for 5 consecutive weekdays at the clinic, plus a pre-treatment MRI and evaluation. - Patients travel from elsewhere in Florida and out of state for the 5-day course. ### Where SAINT® is available SAINT® is delivered on the FDA-cleared Magnus Neuromodulation System, and the number of Verified SAINT® Providers nationwide is limited. Magnus Medical reported in May 2026 that SAINT was available in 14 states. Neuro Wellness TMS Centers of America offers SAINT® at 9734 W Sample Rd, Coral Springs, FL 33065, serving Broward and Palm Beach counties, Fort Lauderdale, Boca Raton, and the Miami area. ### How to vet a SAINT® provider Not every clinic that advertises accelerated TMS offers SAINT®. To confirm a provider truly offers SAINT®, ask: (1) Do you use the Magnus Neuromodulation System with SAINT Technology? (2) Do you use functional MRI targeting to choose the stimulation site? (3) Is the protocol ten sessions per day for five consecutive days? If the answer to any of these is no, the clinic is offering a different accelerated schedule, which is off-label. ### What to plan for in Coral Springs Plan on 5 consecutive weekdays. Each day includes 10 sessions of about 10 minutes with roughly 50-minute breaks, so you will be at the clinic for most of each day. You will also need a psychiatric evaluation and an MRI beforehand, and follow-up visits afterward, some of which may be done remotely or with your home clinician. Patients from elsewhere in Florida and out of state do travel to Coral Springs for the 5-day course. Plan to arrive the day before treatment starts and stay locally for the week. ### Insurance and cost Coverage varies by plan. SAINT® is billed under Category III CPT codes (0889T–0892T), and its manufacturer reports Medicare fee-for-service reimbursement and growing commercial coverage, but many patients still self-pay and prior authorization is common. Neuro Wellness TMS Centers of America verifies benefits before treatment and provides a written estimate. ### FAQ **Where can I get SAINT TMS treatment in Florida?** Neuro Wellness TMS Centers of America offers SAINT® on the FDA-cleared Magnus Neuromodulation System at 9734 W Sample Rd, Coral Springs, FL 33065, serving Broward and Palm Beach counties, Fort Lauderdale, Boca Raton, and the Miami area. Magnus Medical, the manufacturer, reported in May 2026 that SAINT was available in 14 states; ask any provider whether they use the Magnus system and fMRI targeting. **Is SAINT the same as accelerated TMS?** SAINT is one specific accelerated TMS protocol: intermittent theta burst stimulation, 10 sessions per day for 5 days, with functional MRI targeting, delivered on the Magnus Neuromodulation System. Accelerated TMS is a broader term for any TMS schedule with more than one session per day. Only the Magnus system is FDA-cleared for the SAINT protocol; other accelerated schedules are delivered off-label on cleared TMS devices. **Can I drive myself home after SAINT sessions?** Yes, in most cases. SAINT, like other forms of TMS, is delivered while you are awake and does not use anesthesia or sedation, so patients are generally permitted to drive afterward. If you experience a side effect that affects your ability to drive, such as a significant headache or dizziness, tell the treatment team. A companion is optional rather than required. **Do I need an MRI before SAINT?** Yes. The SAINT protocol uses a structural and functional MRI to select an individualized stimulation target in the left dorsolateral prefrontal cortex. The MRI must be completed and processed before the first treatment day, so it is scheduled in advance. Standard MRI safety screening applies, and people who cannot safely have an MRI are not candidates for SAINT. **How long do I need to be in Coral Springs for SAINT?** Plan on 5 consecutive weekdays. Each day includes 10 sessions of about 10 minutes with roughly 50-minute breaks, so you will be at the clinic for most of each day. You will also need an evaluation and an MRI beforehand, and follow-up visits afterward, some of which may be done remotely or with your home clinician. **Who is eligible for SAINT?** The FDA-cleared indication is adults with major depressive disorder who have not achieved satisfactory improvement from prior antidepressant medication in the current episode. Eligibility also depends on TMS and MRI safety screening, including checks for metal implants, implanted devices, and seizure history, and on screening for bipolar disorder, psychosis, and substance use. A psychiatric evaluation determines whether SAINT is appropriate for a specific person. **Does SAINT work for everyone?** No. In the randomized, sham-controlled trial of 29 analyzed adults, 78.6% of the active group met remission criteria at 4 weeks, meaning about one in five did not. The study was small and from a single site, durability beyond 4 weeks is not well established, and some people relapse within months. No provider can guarantee a result from SAINT or any other depression treatment. **Is SAINT covered by insurance in Florida?** Coverage varies by plan. SAINT is billed under Category III CPT codes (0889T–0892T), and its manufacturer reports Medicare fee-for-service reimbursement and growing commercial coverage, but many patients still self-pay and prior authorization is common. Being in-network with a plan does not mean SAINT is covered for a given person. Neuro Wellness TMS Centers of America verifies benefits before treatment; ask for a written estimate. ### Sources 1. Cole EJ, et al. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022;179(2):132-141. https://doi.org/10.1176/appi.ajp.2021.20101429 2. FDA 510(k) Premarket Notification K220177 — Magnus Neuromodulation System with SAINT Technology. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220177 3. Magnus Medical, Inc. — Verified SAINT Provider locator and state availability (May 2026). https://magnusmedical.com/ --- ## Is SAINT® TMS Covered by Insurance, and What Does TMS Cost? Source: https://neurowellnesstms.com/learn/saint-tms-cost-insurance-coverage Conventional TMS is broadly covered by commercial insurance, Medicare, and the VA when medical-necessity criteria are met. SAINT® uses Category III CPT codes and coverage varies by plan — many patients self-pay. Neuro Wellness verifies your benefits at no cost. ### Key Takeaways - Conventional TMS is billed under CPT 90867–90869 and is broadly covered when criteria are met. - SAINT® is billed under Category III CPT codes 0889T–0892T; coverage varies by plan and many patients self-pay. - Verification (benefits check) and prior authorization (clinical review) are different steps; neither guarantees payment. - Most BCBS plans have a written TMS medical policy; Medicare covers TMS under LCDs (First Coast in Florida). - If SAINT® is denied but conventional TMS is covered, most SAINT-eligible patients also qualify for conventional TMS. ### How conventional TMS is covered Conventional repetitive TMS is billed under CPT codes 90867 (initial treatment, including mapping), 90868 (subsequent treatment), and 90869 (treatment management). It is broadly covered by commercial insurance, Medicare, and the VA for treatment-resistant depression when medical-necessity criteria are met — typically including failed antidepressant trials, psychiatrist oversight, and severity scores. ### How SAINT® is covered SAINT® is billed under Category III CPT codes 0889T–0892T, which are newer tracking codes. CMS kept hospital outpatient payment assignments for these codes for 2026, and Magnus Medical reports Medicare fee-for-service reimbursement and growing commercial coverage. However, many plans still treat SAINT® as investigational, prior authorization is common, and many patients self-pay. ### Regulatory status and billing codes TMS devices are FDA-cleared (510(k)), not FDA-approved. Conventional TMS is billed under CPT 90867–90869 (Category I codes with established payment). SAINT® is billed under Category III CPT codes 0889T–0892T (tracking codes for emerging technologies). Category III codes do not guarantee payment — they tell insurers the service exists. Coverage for SAINT® varies by plan and many patients self-pay. ### Verification vs prior authorization Verification is a benefits check: the clinic confirms your plan is active and asks whether the codes are covered, what your cost-sharing is, and whether authorization is needed. Prior authorization is a clinical review in which the plan decides, based on your records, that treatment appears medically necessary. Neither guarantees payment; a claim can still be denied for coding, setting, or eligibility reasons. ### What drives cost Cost depends on the number of sessions, mapping, physician time, the setting, and for SAINT®, an MRI. Published estimates for a full conventional TMS course in the United States commonly fall in the low-to-mid five figures before insurance, and SAINT® is typically priced higher because of the MRI and 50-session schedule. Neuro Wellness TMS Centers of America provides a written estimate after verifying your benefits rather than publishing a single price. ### If you are denied If denied, request the reason, ask your psychiatrist about a peer-to-peer review, and file an appeal within the deadline. If SAINT® is denied but conventional TMS is covered, the clinical eligibility criteria overlap heavily — most people who qualify for SAINT® also qualify for conventional TMS, which takes 4 to 6 weeks of daily visits instead of 5 days. ### FAQ **Is SAINT TMS covered by insurance?** Sometimes, and it depends on your plan. SAINT is billed under Category III CPT codes 0889T–0892T. CMS kept hospital outpatient payment assignments for these codes for 2026, and the manufacturer, Magnus Medical, reports Medicare fee-for-service reimbursement and growing commercial coverage. However, many plans still treat SAINT as investigational, prior authorization is common, and many patients self-pay. The only way to know your situation is verification and, where required, prior authorization. **How much does TMS therapy cost?** Cost depends on the number of sessions, mapping, physician time, the setting, and for SAINT, an MRI. Published estimates for a full conventional TMS course in the United States commonly fall in the low-to-mid five figures before insurance, and SAINT is typically priced higher because of the MRI and 50-session schedule. Neuro Wellness TMS Centers of America provides a written estimate after verifying your benefits rather than publishing a single price. **Does Blue Cross cover TMS therapy?** Blue Cross Blue Shield is a federation of independent plans, so the answer is plan-specific. Most BCBS plans have a written medical policy for repetitive TMS for major depressive disorder, with criteria such as failed antidepressant trials and psychiatrist oversight, and many require prior authorization. Their positions on SAINT's Category III codes vary. Call the number on your card, ask for the TMS medical policy, and have your clinic verify benefits. **How do I get TMS covered by insurance?** Ask your plan for its TMS medical policy, then work with a psychiatrist to document each criterion: a diagnosis of major depressive disorder with severity scores, each antidepressant trial with dose and duration, any psychotherapy, and the absence of exclusions. Your clinic submits this for prior authorization if required. If denied, request the reason, ask your psychiatrist about a peer-to-peer review, and file an appeal within the deadline. **Does Medicare cover TMS in Florida?** Original Medicare covers repetitive TMS for major depressive disorder under Local Coverage Determinations issued by the Medicare Administrative Contractor, which in Florida is First Coast Service Options. The LCD sets medical-necessity criteria such as failed medication trials and psychiatrist supervision. You can read the current LCD on the CMS Medicare Coverage Database. Medicare Advantage plans must cover the same services but may add their own prior-authorization steps. **What is the difference between insurance verification and prior authorization?** Verification is a benefits check: the clinic confirms your plan is active and asks whether the codes are covered, what your cost-sharing is, and whether authorization is needed. Prior authorization is a clinical review in which the plan decides, based on your records, that treatment appears medically necessary. Neither guarantees payment; a claim can still be denied for coding, setting, or eligibility reasons. **Can I use my HSA or FSA to pay for TMS?** Generally, yes. Physician-prescribed, medically necessary treatment such as TMS is typically an eligible expense for health savings accounts and health flexible spending accounts, including deductibles, coinsurance, and self-pay balances. Eligibility rules come from the IRS and your account administrator, so confirm with them and keep itemized receipts. This is general information rather than tax advice. **What if my insurance denies SAINT but covers regular TMS?** This is a common situation. The clinical eligibility criteria for the two treatments overlap heavily, so most people who qualify for SAINT also qualify for conventional TMS, which is covered under established codes when medical-necessity criteria are met. Discuss the trade-offs with your psychiatrist: conventional TMS takes 4 to 6 weeks of daily visits, while SAINT is 5 days but may be self-pay. You can also appeal the SAINT denial. ### Sources 1. CMS Medicare Coverage Database — Local Coverage Determinations for TMS. https://www.cms.gov/medicare-coverage-database/ 2. American Medical Association — CPT Category III codes 0889T–0892T. https://www.ama-assn.org/ 3. Cole EJ, et al. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022;179(2):132-141. https://doi.org/10.1176/appi.ajp.2021.20101429 --- ## What Is Treatment-Resistant Depression, and What Are the Options? Source: https://neurowellnesstms.com/learn/what-is-treatment-resistant-depression Treatment-resistant depression (TRD) is major depressive disorder that has not improved adequately after at least two antidepressant trials of adequate dose and duration. It describes treatment history, not a separate diagnosis. Options include TMS, SAINT®, esketamine, and ECT. ### Key Takeaways - TRD = MDD that has not improved after ≥2 adequate antidepressant trials (adequate dose, 6–8 weeks). - In the STAR*D study, remission rates fell from ~37% (1st medication) to ~13% (4th). - TRD describes treatment history, not a separate diagnosis — it does not mean depression cannot be treated. - Depression can be misdiagnosed as resistant: bipolar disorder, comorbidities, and inadequate trials can mimic resistance. - Options: medication optimization/augmentation, therapy, FDA-cleared TMS/SAINT®, FDA-approved esketamine, ECT. ### What treatment-resistant depression means Treatment-resistant depression is major depressive disorder that has not improved adequately after at least two antidepressant medication trials of adequate dose and duration in the current episode. This is the definition used in the FDA's 2018 draft guidance and in esketamine trials, but definitions vary — some require different drug classes or a psychotherapy trial. It describes treatment history, not a separate diagnosis, and it does not mean the depression cannot be treated. It means the standard first steps have not worked, and it is time to consider other options. ### How common it is: the STAR*D data Roughly one-third of people treated for major depressive disorder do not reach remission after two treatment steps. In the STAR*D study of about 3,671 adults, remission rates were approximately 37% after the first medication, 31% after the second, 14% after the third, and 13% after the fourth. The study was open-label without a placebo group, so exact figures are debated, but the pattern of diminishing returns is well established. ### What counts as an adequate antidepressant trial An adequate trial generally means taking an antidepressant at a therapeutic dose, not just a starting dose, consistently for about 6 to 8 weeks. A medication stopped early because of side effects, or never increased beyond the starting dose, is usually considered an incomplete or intolerable trial rather than a failed one. Reviewing pharmacy records and past prescriptions with a psychiatrist is the first step in deciding whether depression is truly resistant. ### Why it happens and how it is misdiagnosed Depressive episodes in bipolar disorder often respond poorly to antidepressants alone and can be mistaken for resistant unipolar depression. Untreated comorbidities such as anxiety disorders, PTSD, ADHD, or substance use, medical conditions such as hypothyroidism or sleep apnea, and medication trials that were never adequate can all produce the appearance of resistance. A careful reassessment sometimes changes the diagnosis or reveals a correctable cause before new treatments are tried. ### Regulatory status of the options TMS devices (including SAINT® on the Magnus system) are FDA-cleared. Spravato (esketamine) is FDA-approved. ECT is an established psychiatric treatment. No treatment guarantees remission — trial statistics describe groups, not individuals. Every option leaves some people without adequate improvement. A realistic plan sets measurable goals and a reassessment date. ### The full range of options Options for treatment-resistant depression include: medication optimization, switching, or augmentation; psychotherapy (CBT, behavioral activation, interpersonal therapy); repetitive TMS (FDA-cleared); SAINT® accelerated TMS (FDA-cleared); esketamine/Spravato (FDA-approved); and ECT for severe or psychotic depression. The right sequence depends on your history, preferences, and insurance, and should be decided with a psychiatrist. ### FAQ **What is treatment-resistant depression?** Treatment-resistant depression is major depressive disorder that has not improved adequately after at least two antidepressant medication trials of adequate dose and duration in the current episode. This is the definition used in the FDA's 2018 draft guidance and in esketamine trials, but definitions vary; some require different drug classes or a psychotherapy trial. It describes treatment history, not a separate diagnosis, and it does not mean the depression cannot be treated. **How common is treatment-resistant depression?** Roughly one-third of people treated for major depressive disorder do not reach remission after two treatment steps. In the STAR*D study of about 3,671 adults, remission rates were approximately 37% after the first medication, 31% after the second, 14% after the third, and 13% after the fourth. The study was open-label without a placebo group, so exact figures are debated, but the pattern of diminishing returns is well established. **What counts as an adequate antidepressant trial?** An adequate trial generally means taking an antidepressant at a therapeutic dose, not just a starting dose, consistently for about 6 to 8 weeks. A medication stopped early because of side effects, or never increased beyond the starting dose, is usually considered an incomplete or intolerable trial rather than a failed one. Reviewing pharmacy records and past prescriptions with a psychiatrist is the first step in deciding whether depression is truly resistant. **What should I do if I have treatment-resistant depression?** Ask for a full re-evaluation with a psychiatrist. This should include reviewing whether past trials were adequate, screening for bipolar disorder, comorbid conditions, and substance use, and a medical workup including thyroid function. Then discuss the full range of options: medication optimization or augmentation, psychotherapy, FDA-cleared TMS or SAINT, FDA-approved esketamine, or ECT for severe cases. Do not stop current medication on your own, and contact 988 if you have thoughts of self-harm. **What is the newest treatment for depression?** Several options have recent regulatory milestones. The Magnus Neuromodulation System with SAINT Technology, an accelerated fMRI-guided TMS protocol, was FDA-cleared in September 2022. Esketamine (Spravato) was FDA-approved as monotherapy for treatment-resistant depression in January 2025, having first been approved with an oral antidepressant in 2019. Newer does not mean better for every person; each has specific indications, risks, and evidence limits that should be weighed with a psychiatrist. **Is TMS effective for treatment-resistant depression?** Repetitive TMS is FDA-cleared for adults with major depressive disorder who did not improve enough on prior antidepressant medication. In the pivotal randomized sham-controlled trial of 301 adults, active TMS was superior to sham, and a naturalistic study of 307 patients reported about 58% response and 37% remission on clinician-rated scales. Results vary between individuals, the naturalistic study had no control group, and TMS does not help everyone. **Can depression be misdiagnosed as treatment-resistant?** Yes. Depressive episodes in bipolar disorder often respond poorly to antidepressants alone and can be mistaken for resistant unipolar depression. Untreated comorbidities such as anxiety disorders, PTSD, ADHD, or substance use, medical conditions such as hypothyroidism or sleep apnea, and medication trials that were never adequate can all produce the appearance of resistance. A careful reassessment sometimes changes the diagnosis or reveals a correctable cause before new treatments are tried. **Does any treatment guarantee remission from severe depression?** No. Response and remission rates from clinical trials describe groups, not individuals, and every evidence-based option for treatment-resistant depression leaves some people without adequate improvement. ECT has the highest remission rates for severe or psychotic depression but carries anesthesia and cognitive risks. A realistic plan sets measurable goals and a reassessment date, and includes what to try next if a treatment does not help. Be cautious of any provider that promises results. ### Sources 1. Rush AJ, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163(11):1905-1917. 2. FDA Draft Guidance — Major Depressive Disorder: Developing Drugs for Treatment (2018). https://www.fda.gov/ 3. Cole EJ, et al. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022;179(2):132-141. https://doi.org/10.1176/appi.ajp.2021.20101429 --- ## What Are the Options for Treating Depression Without Medication? Source: https://neurowellnesstms.com/learn/depression-treatment-without-medication Non-medication options for depression include psychotherapy (CBT, behavioral activation), exercise, light therapy, and FDA-cleared device treatments like TMS and SAINT®. TMS is a device, not a drug. ### Key Takeaways - For mild–moderate depression, psychotherapy (CBT, behavioral activation, IPT) has the strongest non-drug evidence. - For severe/TRD, FDA-cleared device treatments (TMS, SAINT®) and ECT have the strongest evidence. - TMS is a medical device, not a drug — it introduces no chemical into the body. - No supplement is FDA-approved for depression; St John's wort has important drug interactions. - Do not stop antidepressants abruptly — taper with your prescriber, especially when starting a new treatment. ### Psychotherapy For mild-to-moderate major depression, structured psychotherapy has the strongest non-medication evidence. Cognitive behavioral therapy (CBT), behavioral activation, and interpersonal therapy perform comparably to medication for many people. Therapy is frequently part of a TMS treatment plan and is often covered separately by insurance. ### Lifestyle: exercise, sleep, light therapy Regular exercise, consistent sleep, daylight exposure, and reduced alcohol have evidence for depressive symptoms. Light therapy has evidence for seasonal affective disorder. These are helpful additions and reasonable starting points for mild symptoms, but they are not stand-alone treatments for severe depression. ### Supplements St John's wort has trial evidence for mild-to-moderate depression, but results vary by product and it interacts with many prescription drugs, including antidepressants and hormonal birth control. Omega-3 fatty acids and SAMe have mixed, mostly small-study evidence. No supplement is FDA-approved to treat depression, and none has been shown to work for severe depression. Discuss any supplement with your prescriber before starting it. ### Regulatory status: TMS is a device, not a drug TMS devices (including SAINT® on the Magnus system) are FDA-cleared, not FDA-approved — approval is the process for drugs. TMS uses magnetic pulses to stimulate a specific brain region and introduces no chemical into the body. It is a non-invasive medical device treatment, delivered awake in an outpatient office without anesthesia. No over-the-counter drug is FDA-approved to treat depression. ### Device-based treatments: TMS and SAINT® For severe or treatment-resistant depression, device-based treatments have the strongest evidence. ECT has the highest remission rates for severe or psychotic depression but carries anesthesia and cognitive risks. rTMS and SAINT® are FDA-cleared for adults whose depression has not improved on antidepressant medication and are delivered awake in an outpatient office without anesthesia. ### If antidepressants have already failed If two or more antidepressants have not produced satisfactory improvement, non-drug options include intensive psychotherapy, repetitive TMS, the accelerated SAINT® protocol, and ECT. TMS and SAINT® are FDA-cleared specifically for adults whose depression has not improved on antidepressant medication. Do not stop current medication on your own — ask your prescriber to plan a gradual taper. ### FAQ **What is the most effective non-medication treatment for depression?** It depends on severity. For mild-to-moderate major depression, structured psychotherapy such as cognitive behavioral therapy, behavioral activation, or interpersonal therapy has the strongest evidence and performs comparably to medication for many people. For severe or treatment-resistant depression, device-based treatments have the strongest evidence: ECT has the highest remission rates for severe depression, and rTMS and SAINT are FDA-cleared for adults who have not improved on antidepressants. Exercise and light therapy are helpful additions rather than stand-alone treatments for severe depression. **Is there a natural antidepressant that actually works?** St John's wort has trial evidence for mild-to-moderate depression, but results vary by product and it interacts with many prescription drugs, including antidepressants and hormonal birth control. Omega-3 fatty acids and SAMe have mixed, mostly small-study evidence. No supplement is FDA-approved to treat depression, and none has been shown to work for severe depression. Exercise is arguably the best-supported "natural" option. Discuss any supplement with your prescriber before starting it. **Can I treat depression at home without seeing anyone?** Mild symptoms sometimes improve with regular exercise, consistent sleep, daylight, reduced alcohol, and social contact, and self-guided CBT programs can help. However, depression that lasts more than a few weeks, interferes with work or self-care, or involves any thoughts of death should be evaluated by a professional. Home remedies for depression are a reasonable starting point for mild symptoms, not a substitute for treatment when symptoms are moderate or severe. **How do I fight depression without drugs if antidepressants have already failed?** If two or more antidepressants have not produced satisfactory improvement, you may meet common definitions of treatment-resistant depression. Non-drug options at that stage include intensive psychotherapy, repetitive TMS, the accelerated SAINT protocol, and ECT. TMS and SAINT are FDA-cleared specifically for adults whose depression has not improved on antidepressant medication and are delivered awake in an outpatient office without anesthesia. A psychiatric evaluation can clarify which you are eligible for. **Is TMS considered a medication?** No. Transcranial magnetic stimulation is a medical device treatment, not a drug. It uses magnetic pulses to stimulate a specific brain region and introduces no chemical into the body. TMS devices are FDA-cleared rather than FDA-approved, which is the terminology used for medications. Many people continue an antidepressant during TMS, but TMS itself can be delivered without medication when a clinician judges that appropriate. **Can I stop my antidepressant if I start therapy or TMS?** Not on your own. Stopping abruptly can cause discontinuation symptoms and raises the risk of relapse. If you want to reduce or stop medication, ask your prescriber to plan a gradual taper and to decide the timing relative to any new treatment. Psychotherapy and TMS are both commonly delivered alongside medication, and combining approaches is often more effective than any single one. **Are there over-the-counter medicines for depression?** No. In the United States there is no over-the-counter drug approved by the FDA to treat depression. Products sold for mood support are dietary supplements, which are not reviewed for effectiveness before sale and may not legally claim to treat disease. Some, particularly St John's wort, have important drug interactions. If cost or access to a prescriber is the barrier, community mental health centers and telehealth services are safer routes than self-treating with supplements. **What natural remedies help depression and anxiety together?** Exercise, regular sleep, reduced caffeine and alcohol, and mindfulness- or CBT-based skills have evidence for both depressive and anxiety symptoms. Psychotherapy is effective for both and is usually the first recommendation when they occur together. Some TMS devices are FDA-cleared for anxiety symptoms in adults with major depression, though not for anxiety disorders alone. Supplements marketed for anxiety have limited evidence and can interact with medications. ### Sources 1. Cuijpers P, et al. The effects of psychotherapy for adult depression are overestimated. Psychother Psychosom. 2014;83(5):269-278. 2. Blumenthal JA, et al. Exercise and pharmacotherapy in the treatment of major depressive disorder. Psychosom Med. 2007;69(7):587-596. 3. Cole EJ, et al. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022;179(2):132-141. https://doi.org/10.1176/appi.ajp.2021.20101429 --- ## What Is Spravato® (Esketamine), and How Does It Compare to TMS? Source: https://neurowellnesstms.com/learn/spravato-vs-tms-for-depression Spravato® (esketamine) is an FDA-approved nasal spray for treatment-resistant depression, given in a monitored clinic session of about two hours. TMS is an FDA-cleared device treatment delivered awake with no sedation. Both are options when antidepressants have not worked. ### Key Takeaways - Spravato® is FDA-approved (a drug); TMS devices are FDA-cleared (devices). - Spravato® causes dissociation and requires a 2-hour monitored session and a ride home; TMS has no sedation and no driving restriction. - Spravato® is FDA-approved for TRD and for depressive symptoms with acute suicidal ideation. - A Spravato® induction phase is twice weekly for 4 weeks, then tapers; TMS is ~30–36 sessions over 4–6 weeks (or 5 days for SAINT®). - Spravato® is not the same as IV ketamine — esketamine is FDA-approved for TRD; IV ketamine for depression is off-label. ### What is Spravato® (esketamine)? Spravato® (esketamine) is an FDA-approved nasal spray for treatment-resistant depression in adults. It is an NMDA-receptor antagonist — a different mechanism from standard antidepressants, which mostly target serotonin, norepinephrine, or dopamine. It is self-administered in a certified clinic under supervision, and you are monitored for at least two hours afterward. Spravato® is FDA-approved for two uses: treatment-resistant depression (on its own or with an oral antidepressant), and depressive symptoms in adults with major depressive disorder who have acute suicidal thoughts or behavior (with an oral antidepressant). Any other use is off-label. ### Regulatory status: FDA-approved vs FDA-cleared Spravato (esketamine) is FDA-approved — it went through the drug approval process and is a Schedule III controlled substance under a REMS (Risk Evaluation and Mitigation Strategy) program. TMS devices, including the Magnus Neuromodulation System with SAINT Technology, are FDA-cleared through the 510(k) pathway. Both are legitimate treatments for depression that has not responded to antidepressants, but they are regulated differently because one is a drug and the other is a device. ### What a Spravato® session is like You arrive with a driver, avoid food for two hours and liquids for 30 minutes beforehand, and self-administer the nasal spray under staff supervision with five-minute pauses between devices. Afterward you recline in a monitored room for at least two hours while staff check your blood pressure and how you feel. The most common effect is dissociation — feeling detached from your body or surroundings — which usually peaks around 40 minutes and resolves before discharge. You cannot drive until the next day after a restful sleep. During the induction phase, sessions happen twice a week for four weeks, then weekly, then every one to two weeks. ### How Spravato® compares to TMS The fundamental difference: Spravato® is a drug that acts chemically on NMDA receptors and causes dissociation and sedation; TMS is a device that uses magnetic pulses to stimulate the prefrontal cortex with no sedation and no driving restriction. Spravato® sessions are about two and a half to three hours with monitoring and require a ride home. TMS sessions are about 3 to 40 minutes (depending on protocol), and you drive yourself home. A standard TMS course is about 30 to 36 sessions over four to six weeks; SAINT® compresses TMS into five days. Spravato® and TMS are both options for depression that has not responded to antidepressants — the right choice depends on your history, preferences, and insurance. ### Spravato® vs IV ketamine Spravato® is esketamine (one enantiomer of ketamine), given as a nasal spray at fixed doses and FDA-approved for treatment-resistant depression under a REMS program. IV ketamine uses the full racemic drug, is given by infusion at weight-based doses that vary by clinic, and is off-label for depression because ketamine is FDA-approved only as an anesthetic. Both cause dissociation and require monitoring. Insurance is more likely to cover Spravato® than off-label IV ketamine, because Spravato® has an FDA-approved indication for depression. ### FAQ **What is Spravato used for?** Spravato (esketamine) nasal spray is FDA-approved for two uses in adults: treatment-resistant depression, either on its own or together with an oral antidepressant, and depressive symptoms in adults with major depressive disorder who have acute suicidal thoughts or behavior, together with an oral antidepressant. Treatment-resistant depression generally means major depression that has not improved adequately after at least two antidepressant trials in the current episode. Any other use is off-label. **Are the "Spravato horror stories" online something to worry about?** Most alarming accounts describe dissociation, which is the most common effect of esketamine, reported by 41% of trial patients. Feeling detached from your body or surroundings, dizziness, nausea, sedation, and a temporary rise in blood pressure are expected and are exactly why the FDA requires at least two hours of monitoring in a certified clinic. These effects usually peak around 40 minutes and resolve before discharge. Serious harm is uncommon when contraindications are screened. Tell your team if the experience is distressing; dose and supportive measures can be adjusted. **Is Spravato covered by insurance?** Often, but not automatically. Most commercial plans and Medicare cover Spravato for its FDA-approved indications after prior authorization that documents a diagnosis of major depression and prior antidepressant trials. The drug must be given at a REMS-certified site, and plans may bill the drug and the monitoring separately. Coverage, copays, and site requirements vary by plan, so insurance verification before the first session is essential. Neuro Wellness TMS Centers of America can verify benefits but cannot promise coverage. **What should I do during a Spravato treatment?** Plan to rest. Arrive with a driver, avoid food for two hours and liquids for 30 minutes beforehand, and bring headphones with calm music or an eye mask if that helps you relax. After self-administering the spray under supervision, you recline in a monitored room for at least two hours while staff check blood pressure and how you feel. Reading or working is usually hard during the first hour. You cannot drive until the next day after a restful sleep. **How is Spravato different from TMS?** Spravato is a drug; TMS is a device. Spravato is an NMDA-receptor-blocking nasal spray that causes dissociation and sedation during a two-hour monitored session and requires a ride home. TMS uses magnetic pulses to stimulate the prefrontal cortex while you sit awake in a chair, with no sedation and no driving restriction, over about 30 to 36 sessions (or five days for SAINT). Spravato is FDA-approved; TMS devices are FDA-cleared. Both are options for depression that has not responded to antidepressants. **How long does a Spravato session take?** Plan for about two and a half to three hours. That includes a pre-dose blood pressure check, self-administration with five-minute pauses between devices, at least two hours of required monitoring, and a discharge assessment. During the induction phase this happens twice a week for four weeks, then weekly, then every one to two weeks. **Does Spravato have off-label uses?** Some prescribers use Spravato off-label for conditions such as bipolar depression, PTSD, or anxiety disorders. Off-label prescribing is legal, but these uses are not FDA-approved, the evidence for them is thinner than for treatment-resistant depression, and insurance generally does not cover them. Ask your clinician directly whether a proposed use is on-label and what evidence supports it. **Is Spravato the same as ketamine infusions?** No. Spravato is esketamine, one half of the ketamine molecule, given as a nasal spray at fixed doses and FDA-approved for treatment-resistant depression under a REMS program. IV ketamine uses the full racemic drug, is given by infusion at weight-based doses that vary by clinic, and is off-label for depression because ketamine is FDA-approved only as an anesthetic. Both cause dissociation and require monitoring; insurance is more likely to cover Spravato. ### Sources 1. FDA Label, Spravato (esketamine) Nasal Spray. Janssen Pharmaceuticals, Inc. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211243s019lbl.pdf 2. Popova V, et al. Efficacy and safety of flexibly dosed esketamine nasal spray combined with a newly initiated oral antidepressant in adult patients with treatment-resistant depression. Am J Psychiatry. 2019;176(6):428-438. 3. Cole EJ, et al. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022;179(2):132-141. https://doi.org/10.1176/appi.ajp.2021.20101429 --- ## Can TMS Help With Anxiety, OCD, PTSD, or Bipolar Depression? Source: https://neurowellnesstms.com/learn/tms-for-anxiety-ocd-ptsd TMS is FDA-cleared for anxiety symptoms in adults with major depression and for OCD (on the BrainsWay H7 coil). TMS for PTSD and bipolar depression is off-label and not FDA-cleared. ### Key Takeaways - TMS is FDA-cleared for anxiety symptoms in adults with MDD (BrainsWay 2021, NeuroStar 2022) — not for anxiety disorders alone. - TMS is FDA-cleared for OCD on the BrainsWay H7 coil (De Novo, 2018). - TMS for PTSD is off-label and unproven; no device is FDA-cleared for PTSD. - TMS for bipolar depression is off-label and carries a small risk of triggering mania. - Off-label use is legal but evidence is weaker and insurance rarely pays. ### TMS for anxiety TMS is FDA-cleared for anxiety symptoms in adults who have major depressive disorder, on the BrainsWay (2021) and NeuroStar (2022) systems. In that population, anxiety typically improves alongside depression, because the stimulated region (the left dorsolateral prefrontal cortex) is involved in regulating both mood and worry. TMS is not FDA-cleared for generalized anxiety disorder, panic disorder, or social anxiety on their own. Small studies exist, but there is no pivotal trial. If you have anxiety without depression, psychotherapy and medication remain the evidence-based first-line treatments, and any TMS would be off-label. ### TMS for OCD TMS is FDA-cleared for obsessive-compulsive disorder on one device: BrainsWay Deep TMS with the H7 coil, granted FDA marketing authorization through the De Novo pathway in 2018. The clearance was based on a multicenter sham-controlled trial in adults whose OCD had not responded adequately to prior treatment. Sessions target the medial prefrontal and anterior cingulate cortices and include brief symptom provocation. Other TMS devices are not cleared for OCD unless their labeling says so. If a clinic offers TMS for OCD, ask which device and coil it uses and whether that device is FDA-cleared for OCD. ### TMS for PTSD TMS for PTSD is unproven. Several small randomized trials, including research within the Department of Veterans Affairs, have tested TMS for PTSD with different targets and frequencies; some showed benefit over sham and others did not. No TMS device is FDA-cleared for PTSD, so any use is off-label and usually not covered by insurance. Trauma-focused psychotherapies — EMDR, prolonged exposure, and cognitive processing therapy — remain the first-line treatments for PTSD. Neuro Wellness TMS Centers of America also offers Prism, an EEG-based neurofeedback approach for PTSD. ### TMS for bipolar depression TMS for the depressive phase of bipolar disorder is off-label. Randomized trials have had mixed results and small samples, and no device is FDA-cleared for bipolar disorder. TMS carries a small risk of triggering mania or hypomania, so it should not be given during a manic episode and, if used at all, requires a mood stabilizer and close monitoring. First-line treatments for bipolar depression are mood-stabilizing medications and, for severe episodes, ECT. ### Regulatory status: what off-label means TMS devices are FDA-cleared for specific indications. Using a cleared device for a condition it is not cleared to treat (such as PTSD or bipolar depression) is off-label: legal, but the evidence is typically weaker or mixed and insurance rarely pays. You should be told explicitly when a proposed treatment is off-label and give informed consent. No provider should imply that off-label TMS is FDA-cleared for that condition. ### FAQ **Can TMS help anxiety?** TMS is FDA-cleared for anxiety symptoms in adults who have major depressive disorder, on the BrainsWay (2021) and NeuroStar (2022) systems. In that group, anxiety typically improves alongside depression. TMS is not FDA-cleared for generalized anxiety disorder, panic disorder, or social anxiety on their own; small studies exist but there is no pivotal trial. If you have anxiety without depression, psychotherapy and medication remain the evidence-based first-line treatments, and any TMS would be off-label. **Is TMS FDA-cleared for OCD?** Yes, for one device. BrainsWay Deep TMS with the H7 coil was granted FDA marketing authorization for obsessive-compulsive disorder through the De Novo pathway in 2018, based on a multicenter sham-controlled trial in adults whose OCD had not responded adequately to prior treatment. Sessions target the medial prefrontal and anterior cingulate cortices and include brief symptom provocation. Other TMS devices are not cleared for OCD unless their labeling says so. **Does TMS work for PTSD?** It is unproven. Several small randomized trials, including research within the Department of Veterans Affairs, have tested TMS for PTSD with different targets and frequencies; some showed benefit over sham and others did not. No TMS device is FDA-cleared for PTSD, so any use is off-label and usually not covered by insurance. Trauma-focused psychotherapies such as EMDR, prolonged exposure, and cognitive processing therapy remain the first-line treatments. **Can TMS be used for bipolar depression?** Only off-label, and with caution. Randomized trials of TMS for the depressive phase of bipolar disorder have had mixed results and small samples, and no device is FDA-cleared for bipolar disorder. TMS carries a small risk of triggering mania or hypomania, so it should not be given during a manic episode and, if used at all, requires a mood stabilizer and close monitoring. First-line treatments are mood-stabilizing medications and, for severe episodes, ECT. **What does "off-label" TMS mean?** Off-label means a clinician uses an FDA-cleared TMS device for a condition the device is not cleared to treat, such as PTSD or bipolar depression. This is legal, and physicians may do it when they judge the evidence and risks acceptable, but the manufacturer cannot promote that use, the supporting evidence is typically weaker or mixed, and insurance rarely pays. You should be told explicitly when a proposed treatment is off-label and give informed consent. **Is magnetic therapy for anxiety the same as TMS?** No. Consumer "magnetic therapy" products such as bracelets, mats, or static magnets are not TMS and have no evidence for anxiety or depression. TMS uses a powerful, rapidly changing electromagnetic field generated by a medical device, operated by trained staff under a physician's supervision, to induce electrical currents in specific brain regions. Only prescription TMS systems are FDA-cleared, and only for the indications on their labeling. **Can TMS treat eating disorders?** Not as an established treatment. Studies of TMS for anorexia nervosa, bulimia nervosa, and binge eating disorder are small and early-stage, with inconsistent findings, and no device is FDA-cleared for any eating disorder. Marketing that suggests otherwise is not supported by evidence. Eating disorders are best treated by specialized programs combining nutritional rehabilitation, psychotherapy, and medical monitoring; TMS should be considered only within a research study. **How does TMS treat depression and anxiety at the same time?** In adults with major depression, standard TMS protocols stimulate the left dorsolateral prefrontal cortex, a region involved in regulating both mood and worry. Trials measuring anxiety scales in depressed patients found anxiety symptoms improved along with depression, which supported the anxious-depression clearances. The same course of about 30 to 36 sessions addresses both; there is no separate "anxiety protocol." Because the evidence comes from people with depression, this does not establish that TMS treats anxiety disorders in people without depression. ### Sources 1. Carmi L, et al. Efficacy and safety of deep transcranial magnetic stimulation for obsessive-compulsive disorder: A prospective multicenter randomized double-blind placebo-controlled trial. Am J Psychiatry. 2019;176(11):931-938. 2. FDA De Novo authorization, BrainsWay Deep TMS H7 coil for OCD (2018). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm 3. Cole EJ, et al. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022;179(2):132-141. https://doi.org/10.1176/appi.ajp.2021.20101429 --- ## How Do TMS Devices Differ? SAINT®, NeuroStar®, BrainsWay®, and Exomind™ Compared Source: https://neurowellnesstms.com/learn/tms-devices-compared-saint-neurostar-brainsway-exomind TMS devices differ in coil design, FDA-cleared indications, and protocol. NeuroStar (figure-8 coil) and BrainsWay (H-coil) are standard once-daily systems. SAINT® (Magnus) is the only FDA-cleared accelerated protocol. Exomind is a newer device often marketed off-label. ### Key Takeaways - NeuroStar (figure-8 coil, 2008) and BrainsWay (H-coil, deeper stimulation) are the two most common conventional TMS systems. - BrainsWay H7 coil is FDA-cleared for OCD; NeuroStar is cleared for anxious depression and adolescents 15–21. - SAINT® (Magnus, K220177) is the only accelerated TMS protocol with its own FDA clearance. - Exomind (BTL) is cleared for depression but often marketed off-label for brain fog, focus, etc. - No head-to-head trial shows one device is more effective than another; the clinic and protocol matter more than the brand. ### NeuroStar® Advanced Therapy NeuroStar, made by Neuronetics, was the first TMS device FDA-cleared for depression, in October 2008. It uses a figure-8 coil positioned over the left dorsolateral prefrontal cortex to deliver 10 Hz magnetic pulses in sessions of roughly 19 to 37 minutes, five days a week for about four to six weeks. NeuroStar is cleared for adults with major depressive disorder who have not improved on antidepressant medication, for anxiety symptoms in adults with MDD (2022), and for adolescents aged 15 to 21 (2024). It is one of the most widely used TMS systems in the United States. ### BrainsWay Deep TMS BrainsWay uses an H-coil inside a helmet that stimulates a deeper and broader area than a figure-8 coil. It is FDA-cleared for depression, anxious depression (2021), OCD (2018, H7 coil), and smoking cessation (2020). No head-to-head randomized trial has shown BrainsWay to be more effective than NeuroStar for depression. The choice between them often comes down to the clinic's preference and the specific indication. ### SAINT® (Magnus Neuromodulation System) SAINT® is the only accelerated TMS protocol with its own FDA clearance (510(k) K220177, September 2022). It delivers ten iTBS sessions per day for five consecutive days, with the stimulation target chosen from each patient's functional MRI. It is cleared for adults with major depressive disorder who did not improve enough on antidepressant medication. SAINT® has never been compared head-to-head with a standard six-week course. Its advantages are the five-day schedule and MRI-based targeting; its limitations are limited durability data, the MRI requirement, and cost. ### Exomind™ (BTL Industries) Exomind is a 510(k)-cleared TMS device made by BTL Industries, marketed since 2024. Its clearance is for depression in adults. It is often offered in med spas and wellness clinics with claims about brain fog, focus, perimenopause, or binge eating — those uses are off-label, and a 2026 Clinical TMS Society journal statement found them unsupported by peer-reviewed evidence. If you are offered Exomind, ask whether a psychiatrist will evaluate you and whether the use is within the cleared indication. ### Regulatory status and how to choose All of these devices are FDA-cleared (510(k)), not FDA-approved — that term applies to drugs. No large randomized trial has compared manufacturers' devices against each other. What matters more than the brand is whether the device is FDA-cleared for your diagnosis, whether the protocol is supported by published trials, whether a psychiatrist supervises your care, and what the plan is if you do not improve. Deep brain stimulation (DBS) is neurosurgery and is not TMS. ### FAQ **What is NeuroStar TMS therapy?** NeuroStar is a repetitive TMS system made by Neuronetics and was the first TMS device FDA-cleared for depression, in October 2008. It uses a figure-8 coil positioned over the left prefrontal cortex to deliver 10 Hz magnetic pulses in sessions of roughly 19 to 37 minutes, five days a week for about four to six weeks. It is cleared for adults with major depressive disorder who have not improved on antidepressant medication, for anxiety symptoms in adults with MDD, and, since 2024, for adolescents aged 15 to 21. **What is the difference between BrainsWay and NeuroStar?** Both are FDA-cleared rTMS systems for depression. NeuroStar uses a focal figure-8 coil; BrainsWay uses an H-coil inside a helmet that stimulates a deeper and broader area. BrainsWay additionally holds clearances for OCD (2018), smoking cessation (2020), and anxious depression (2021); NeuroStar holds clearances for anxious depression (2022) and adolescents (2024). No head-to-head randomized trial has shown one to be more effective than the other for depression. **What is BrainsWay accelerated TMS or the "swift protocol"?** Some clinics deliver more than one BrainsWay Deep TMS session per day and describe this as accelerated or "swift" treatment. Accelerated schedules on conventional devices are off-label modifications of the cleared once-daily protocol, and their evidence base is smaller and more varied than for standard courses. The only accelerated TMS protocol with its own FDA clearance is SAINT on the Magnus Neuromodulation System. Ask any clinic offering accelerated TMS whether the schedule is cleared or off-label. **What is Exomind therapy?** Exomind is a 510(k)-cleared TMS device made by BTL Industries, a company best known for aesthetic equipment, and has been marketed since 2024. Its clearance is for depression in adults. It is often offered in med spas and wellness clinics with claims about brain fog, focus, perimenopause, or binge eating; those uses are off-label, and a 2026 Clinical TMS Society journal statement found them unsupported by peer-reviewed evidence. If you are offered Exomind, ask whether a psychiatrist will evaluate you and whether the use is within the cleared indication. **Is SAINT better than regular TMS?** Not established. SAINT produced a 78.6% remission rate versus 13.3% for sham at four weeks in a single-site randomized trial of 29 analyzed patients, which is a striking result but from a very small study with short follow-up. It has never been compared head-to-head with a standard six-week course. SAINT's advantages are its five-day schedule and MRI-based targeting; its limitations are limited durability data, the MRI requirement, and cost, since it is often self-pay. **Is deep brain stimulation the same as TMS?** No. Deep brain stimulation is neurosurgery: electrodes are implanted deep in the brain and connected to a battery under the skin of the chest. It is approved for Parkinson's disease and essential tremor and remains investigational for depression, with mixed trial results. TMS is non-invasive, delivered through a coil on the scalp in an outpatient office, with no surgery or anesthesia. No office-based magnetic treatment is "deep brain stimulation," even if marketed with that phrase. **What is the best TMS machine?** There is no evidence-based answer, because no large randomized trial has compared manufacturers' devices against each other. What matters more is whether the device is FDA-cleared for your diagnosis, whether the protocol you will receive is supported by published trials, whether a psychiatrist supervises your care, how response will be measured, and what the plan is if you do not improve. A well-run clinic using any cleared device for its cleared indication is a better choice than a newer machine used off-label. **What is Ampa TMS?** Ampa One is a newer TMS system that appears in patient searches. Reliable, verified details about its cleared indication, coil design, and protocol were not available for this article, so we do not describe them. Before considering treatment on any device, search the FDA's 510(k) database by device or manufacturer name to confirm what it is cleared for, and ask the clinic the same questions you would ask about any TMS system. ### Sources 1. FDA 510(k) Premarket Notification K220177 — Magnus Neuromodulation System with SAINT Technology. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K220177 2. Neuronetics, Inc. NeuroStar Advanced Therapy TMS System — FDA clearances and indications. https://neurostar.com/ 3. BrainsWay Ltd. Deep TMS System — FDA clearances and indications. https://brainsway.com/ 4. Cole EJ, et al. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022;179(2):132-141. https://doi.org/10.1176/appi.ajp.2021.20101429 --- ## SAINT® TMS for Blue Cross and Blue Shield of Illinois (BCBSIL) Members Source: https://neurowellnesstms.com/bcbs-illinois-saint This page helps Blue Cross and Blue Shield of Illinois (BCBSIL) members — and employees of BCBSIL group-plan employers — quickly check whether SAINT® (Stanford Accelerated Intelligent Neuromodulation Therapy) may be covered under their plan and start a free consultation. The page is dynamically personalized: when an employer name is passed in the URL (e.g. `?employer=Caterpillar`), the hero, headings, and form copy reference that employer so the visitor recognizes their workplace benefit. The captured employer name is also attached to the lead submitted to the CRM. **Who it is for:** Adults 22 and older whose depression has not improved with antidepressant medication, as well as eligible family members on the same BCBSIL policy. A parent can inquire for themselves or for an adult child on their plan. **The problem:** Many people have done everything they were supposed to do — therapy, multiple medications, waiting — and are still depressed. Standard TMS takes 6 to 9 weeks of daily sessions, which is hard to fit around work and family. **The solution:** SAINT® is an FDA-cleared, fMRI-guided accelerated TMS protocol that delivers 50 sessions over five days. An fMRI maps each person's brain to target the stimulation site individually. Treatment is outpatient at the Coral Springs, Florida clinic; the consultation happens over Zoom and a travel coordinator helps plan the treatment week. The clinic orders and coordinates the required 45-minute brain scan. **The benefit:** In a controlled clinical trial, 79% of participants reached remission, on average in 2.6 days. Individual results vary. Treatment is completed in one week instead of 6 to 9 weeks. **Insurance and coverage:** SAINT may be covered under a member's BCBSIL plan, including employer group plans, for the member and eligible family members. Coverage depends on the specific plan and requires prior authorization; it is not guaranteed, and self-pay is available. The clinic verifies benefits and handles the paperwork, and the patient knows their cost before committing. **Frequently asked questions:** - **Does SAINT hurt?** Most people describe a tapping feeling on the scalp. The most common side effects in clinical trials were mild headache and temporary scalp discomfort. You stay awake the whole time, with no anesthesia. - **Is SAINT safe?** SAINT is FDA-cleared and noninvasive. More than 400 patients have been treated in clinical trials with no serious adverse events reported. Rare risks include seizure, and your clinician will review every risk with you. - **Will my BCBSIL plan cover it?** It depends on your specific plan, and it requires prior authorization. We verify your benefits and handle the paperwork, and you'll know your cost before you commit. Coverage isn't guaranteed, and self-pay is available. - **Can family members on my plan be treated?** Adults 22 and older on your plan whose depression hasn't improved with medication may be eligible. Each person gets their own free consultation. - **Do I need to get my own MRI?** No. We order and coordinate your 45-minute brain scan for you. - **Where does treatment happen?** At our clinic in Coral Springs, Florida. Your consultation happens over Zoom, and our travel coordinator helps you plan your treatment week. **Key takeaways:** SAINT® is an FDA-cleared, MRI-guided TMS treatment for adults 22+ whose depression hasn't improved with antidepressants. Treatment takes five days, compared with 6 to 9 weeks for standard TMS. In a controlled clinical trial, 79% of participants reached remission (individual results vary). SAINT may be available through a BCBSIL plan for the member and eligible family members. The clinic verifies benefits and handles prior authorization, and the patient knows their cost before committing. **Medically reviewed by:** Daniel Pietras, MD, Board-Certified Psychiatrist, Medical Director. Published and last reviewed September 24, 2026. ### Sources 1. Cole EJ, et al. Stanford Neuromodulation Therapy (SNT): A Double-Blind Randomized Controlled Trial. Am J Psychiatry. 2022;179(2):132-141. https://pubmed.ncbi.nlm.nih.gov/35624717/ 2. Cole EJ, et al. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020;177:716-726. https://pubmed.ncbi.nlm.nih.gov/32552917/ 3. FDA 510(k) clearance K220177, SAINT Neuromodulation System. https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220177.pdf 4. Magnus Medical clinical research. https://www.magnusmedical.com/clinical-research/ 5. Stanford Brain Stimulation Lab. https://med.stanford.edu/brainstimulationlab.html --- ## Contact and Consultation Neuro Wellness TMS Centers of America 9734 West Sample Road, 2nd Floor, Suite B, Coral Springs, FL 33065 Phone: 954-827-9793 (tel:+19548279793) Website: https://neurowellnesstms.com Services offered: SAINT® Accelerated TMS, standard TMS, AMPA, SPRAVATO® (esketamine), Prism for PTSD, Proliv Rx at-home neuromodulation, IV ketamine infusions, ketamine-assisted psychotherapy, psychotherapy (CBT, DBT, EMDR), and medication management. Conditions treated: Treatment-resistant depression, anxiety, PTSD, OCD, bipolar depression, suicidal ideation, chronic pain, CRPS, fibromyalgia, migraines, neuropathic pain. Serving: Coral Springs, Broward County, Miami-Dade County, Palm Beach County, Fort Lauderdale, Boca Raton, and the Miami area. If you are thinking about harming yourself, call or text 988 (Suicide & Crisis Lifeline) in the U.S., or go to the nearest emergency room. --- *Content on this site is for education only and is not a substitute for individualized medical advice, diagnosis, or treatment. Treatment eligibility, insurance coverage, and outcomes vary by patient. Medical devices (SAINT/Magnus, NeuroStar, BrainsWay, MagVenture, BTL/Exomind) are FDA-cleared. Spravato is FDA-approved. Never use the word "FDA-approved" for TMS devices. Individual results vary and no outcome is guaranteed.*