What is TMS therapy?
Transcranial Magnetic Stimulation (TMS) is a technological breakthrough in the treatment of Major Depression, PTSD, Anxiety, and other disorders. It is an FDA-approved, non-invasive treatment that has been recognized by the American Psychiatric Association in its Best Practices Guidelines as an effective treatment for depression. What is TMS? It’s a safe and effective outpatient treatment for individuals diagnosed with Major Depressive Disorder (MDD) or similar disorders who have not experienced satisfactory improvement from antidepressant medication.
TMS therapy differs from traditional drug therapy because it employs MRI-strength magnetic pulses that are targeted only to specific regions of the brain involved in mood regulation – areas known to be under-active in those diagnosed with MDD. TMS activates and raises the levels of neurotransmitters in the brain – dopamine, norepinephrine, and serotonin – and can be used in conjunction with medication or as a stand-alone treatment.
Neuro Wellness TMS Centers of America utilizes TMS devices that are FDA-cleared and indicated for the treatment of MDD. These devices delivers magnetic pulses, stimulating specific areas of the brain involved in mood regulation. These areas are known to be underactive in those diagnosed with depression, & stimulating these areas can improve the brain’s ability to regulate mood.
TMS is non-invasive, meaning that it does not involve any anesthesia or sedation, as the patient remains awake and alert during the treatment. It is also non-systemic, meaning that it does not circulate in the bloodstream throughout the body. Side effects frequently experienced from antidepressant medications (i.e. weight gain, sexual dysfunction, tiredness, etc) do not occur with TMS therapy.
In FDA clinical trials, 2 out of every 3 patients reported remission or a reduction in depression symptoms after completion of TMS Therapy. Subsequent studies have consistently shown 3 out of every 4 patients positively responding to TMS. What is TMS? Learn more about clinical results.
Is TMS right for me?
TMS therapy is a non-invasive, non-drug, FDA-cleared treatment for individuals diagnosed with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from 1 prior anti-depressant medication. However, to be covered by insurance, most companies require that a patient has failed to achieve satisfactory improvement from at least 3 or 4 prior anti-depressant medications.
TMS Therapy is contraindicated in individuals with implanted metallic devices or non-removable metallic objects in or around the head.
To determine if TMS is right for you, please answer the following questions. If you answer “yes” to two or more questions, then TMS therapy may help you:
- Are you on more than one anti-depressant medication?
- Is your current medication failing to provide adequate benefit for your depression?
- Do the side effects from your medication outweigh the benefit?
- Has depression increased your doctor visits for other healthcare conditions?
- Is depression affecting your ability to make a living?
- Does depression still have too much control over your life?
The Neuro Wellness TMS Therapy process ensures the highest level of patient care. Once you fill out a Consultation Form or receive a referral from your Doctor, we will reach out to schedule your Complimentary Consultation. During the Consultation, a Neuro Wellness Patient Consultant will meet with you to obtain your medical history and review your insurance information. Patients who are ready to begin treatment will then meet with a Neuro wellness Psychiatrist for a Pre-Assessment. Once the Pre-Assessment is complete, the Psychiatrist will determine if TMS Therapy is appropriate for you. Eligible candidates will then begin their TMS treatment.
Typical TMS Treatment
Although treatment varies by individual, a typical treatment course consists of:
✔ Average of 30-36 treatment sessions
✔ Conducted over a 4-6 week period
✔ 5 treatments per week
✔ Each treatment session lasts approximately 19-37 minutes
What to expect
During treatment, patients relax in a treatment chair and remain awake and alert. The TMS Therapy device will deliver magnetic pulses to specific areas of your brain known to regulate mood. These pulses will feel like tapping on the scalp. The technician can make adjustments if the tapping is uncomfortable. Mild headache or scalp discomfort is sometimes experienced at the site of stimulation during or after treatment. Over-the-counter analgesic may be taken to alleviate discomfort. If discomfort persists, the strength of the magnetic field pulses can be reduced to make treatment more comfortable.
After a treatment session, patients can immediately return to their normal routine, including driving. In clinical trials, most patients experienced a positive response to TMS Therapy by the fourth week of treatment. Some patients may experience results in less time, while others may take longer. It is important to continually discuss any depression symptoms with your TMS Technician.
Your first treatment session
Because it is important to determine how to most effectively administer your individual treatment, your first treatment session can last up to 90 minutes, as one of our practitioners will determine the appropriate placement and energy settings of the treatment coil. You will be provided with earplugs to reduce the audible tapping sound that the device emits. You can bring your own headphones (providing they are not metal) and listen to music during your treatment. Placement of the treatment coil and strength of the magnetic field are important factors in successful TMS treatment and each patient requires customized settings to ensure the correct treatment dose. In order to do this, a test will be performed to identify your motor threshold; the amount of magnetic field strength resulting in a movement of the fingers on your right hand. From there, the coil is moved to the left frontal lobe, specifically the Dorsal Lateral Prefrontal Cortex (DLPFC), where treatment begins.
Benefits of TMS Therapy
Nothing enters the bloodstream
Patient remains awake and alert during treatment and can resume usual routine
Nothing is inserted or implanted into the body
No drug related side effects such as weight gain, drowsiness, sleeplessness, stomach upset or sexual problems
FDA Cleared & Proven
2 out of every 3 patients had a reduction in depression scores after a 4-week treatment period
Covered by Most Insurance Plans
We assist patients with the reimbursement and financing process
TMS Clinical Study Results
TMS Therapy was cleared by the FDA in 2008 after a decade of clinical trials. As such, the actual administering of TMS is very precise and well regulated. Since TMS Therapy was first introduced, the evidence for the clinical efficacy of treating patients in the prefrontal cortex for major depression spans more than 30 randomized, controlled trials in thousands of patients. Overall, these reports represent a comprehensive and consistent literature in which conclusions dramatically substantiate the effectiveness of TMS Therapy.
Shown below are the TMS clinical results of three separate studies representing a total of 462 patients with treatment performed at over 40 different locations nationwide.
Study 1: Dunner 2014
In a naturalistic clinical study in 257 patients who did not benefit from antidepressant medications, TMS Therapy offered durable effect over 1 year following acute treatment. The study was conducted at 42 different sites, of which 76% were in private clinical practices, 17% in academic medical centers, and 7% within nonacademic institutional settings. The distribution of practice types participating in the study mirrors those currently offering TMS Therapy in the United States. The TMS clinical results were impressive: 67.7% of patients responded to treatment and 45.1% reached remission.
While the results at the end of the initial treatment (end of acute phase) indicated a response rate of 62.3% and a remission rate of 41.2%, the results improved when compared 12 months later. The improvement is partially a result of “reintroduction treatments” that were reintroduced to 36.2% of patients (average of 16 treatments).
Study 2: Vaché 2013
In this study, 82 patients were treated with TMS Therapy and evaluated using the IDS-SR30 symptom severity scale immediately before and after treatment. The mean IDS-SR30 symptom severity scale before treatment was 42.8 and reduced to 20.1 at the end of treatment. Fifty percent of the patients included in this evaluation had a prior history of hospitalization related to their depressive symptomatology. TMS sessions were conducted 5 days per week for a minimum of 2 weeks with a mean of 32.8 treatments per acute phase. The results were impressive with 55 of the 82 (67.1%) patients positively responding to TMS treatment and with 38 of 82 (46.3%) patients identified to be in remission. Response rates were determined based upon a minimum of a 50% reduction in symptom score compared to the baseline. No significant adverse events were experienced during or after treatment.
Study 3: Cress 2015
In this study, 123 patients with unipolar, non-psychotic MDD who had failed to receive benefit from prior antidepressant treatment were given TMS Therapy using the NeuroStar TMS Therapy System (Neuronetics, Inc., Malvern, PA, USA). Patients were treated daily (five days a week for approximately four to six weeks). The study’s primary outcome of interest was the change in depressive symptoms utilizing the Beck Depressive Inventory Scale (BDI II). The mean baseline score was 25.6, indicating moderate depression with a mean end point score of 10.2 by the end of the study, indicating remission. Overall, 89 out of the 123 patients (72.4 percent) achieved remission of symptoms during acute treatment. There were no serious adverse events reported. From this patient population, 10 patients who achieved remission in the acute phase of TMS were evaluated over the course of four years, with over 80.0 percent of patients maintaining remission from their depression.
*TMS Therapy has also undergone, or is currently undergoing, hundreds of clinical trials for the treatment of many other disorders, including: ADD, PTSD, bi-polar disorder, autism, chronic pain, epilepsy, obesity, smoking cessation, Fibromyalgia, Parkinson’s and Alzheimer’s. Many leading medical universities and institutions are involved in these clinical trials, including Columbia, Duke, Harvard, Johns Hopkins, Mayo Clinic, Stanford, UCLA, University of Pennsylvania, and Walter Reed National Military Medical Center.
For more information on past and current clinical trials involving Transcranial Magnetic Stimulation, visit the U.S. National Institutes of Health website.
With more than 10,000 treatments performed in clinical trials, the most common side effect associated with TMS Therapy was mild-moderate scalp discomfort. Other common side effects included minor twitching around the eye; minor twitching of facial muscles; toothache; and mild-moderate headache. Side effects usually resolve by end of each treatment session period. There is a rare risk of seizure associated with TMS Therapy (0.1% per acute treatment course).
Transcranial Magnetic Stimulation FAQs
TMS stands for transcranial magnetic stimulation. It is used to treat depression by stimulating the brain non-invasively using electromagnetic fields, similar to those produced by an MRI machine. During TMS Therapy, a magnetic field is administered in very short pulses to the part of the brain that research has demonstrated to be associated with depression. The typical initial course of treatment is about 19-37 minutes daily over 4-6 weeks.
The NeuroStar TMS Therapy system uses short pulses of magnetic fields to stimulate the area of the brain that is thought to function abnormally in patients with depression. The magnetic field produces an electric current in the brain that stimulates the brain cells (neurons). This results in changes that are thought to be beneficial in the treatment of depression.
It usually takes time for healthcare insurers to establish coverage policies for newly approved treatments such as NeuroStar TMS. However, many commercial and Medicare plans have recognized the effectiveness of treating depression with TMS Therapy and now cover TMS as part of their plans. See here for a full list of insurance plans that cover TMS.
NeuroStar® is non-systemic (does not circulate in the blood throughout the body), so it does not have side effects such as weight gain, sexual dysfunction, nausea, dry mouth, sedation, etc. The most common side effects reported during clinical trials were headache and scalp discomfort – generally mild to moderate – occurring less frequently after the first week of treatment.
No. TMS Therapy involves a unique method of using pulsed magnetic fields for therapeutic benefit. The intensity of the magnetic field is similar to that of the magnetic fields used in magnetic resonance imaging, or MRI. These techniques differ radically from the popular use of low intensity, static magnetic fields. These products deliver weak and undirected static fields that are not capable of activating brain cells.
No, the two procedures are very different. While both are effective in the treatment of depression, there are many differences in safety and tolerability.
During TMS Therapy, patients sit in a chair and are awake and alert throughout the entire 19-37 minute procedure – no sedation is used with TMS Therapy. Patients can transport themselves to and from treatment.
In over 10,000 active treatments with the NeuroStar TMS Therapy system in clinical trials, no seizures were observed. TMS Therapy was also shown to have no negative effects on memory function in these studies.
In contrast, “shock therapy,” or electroconvulsive therapy (ECT), intentionally causes a seizure. Patients receiving ECT must be sedated with general anesthesia and paralyzed with muscle relaxants. Recovery from an ECT treatment session occurs slowly, and patients are usually closely monitored for minutes or a even few hours after a treatment.
Short-term confusion and memory loss are common with ECT, and long-term disruptions in memory have been shown to occur and may persist indefinitely in some people. Because of the side effects associated with ECT, a significant amount of caregiver support is required.
A typical course of TMS Therapy is 5 times per week for 19-37 minutes sessions, depending on what the doctor determines is the correct protocol, over 4-6 weeks.
Any additional treatments are based on clinical judgment.
NeuroStar TMS Therapy has been shown to be well tolerated and the Neurostar TMS Therapy system has been demonstrated to be safe in clinical trials. Throughout over 10,000 active treatments performed in clinical trials, the most commonly reported side effect related to treatment was scalp discomfort during treatment sessions. This side effect was generally mild to moderate, and occurred less frequently after the first week of treatment. Less than 5% of patients treated with NeuroStar TMS Therapy discontinued treatment due to side effects.
In NeuroStar clinical trials, over 10,000 TMS treatments demonstrated its safety, with no occurrence of seizures. However, there is a small risk of a seizure occurring during treatment. This risk is no greater than what has been observed with oral antidepressant medications.
While NeuroStar TMS Therapy has been demonstrated to be effective, not all patients will benefit from it. Patients should be carefully monitored for worsening symptoms, signs or symptoms of suicidal behavior, and/or unusual behavior. Families and caregivers should also be aware of the need to observe patients and notify their treatment provider if symptoms worsen.
No, NeuroStar TMS Therapy uses the same type and strength of magnetic fields as MRIs (magnetic resonance imaging), which have been used in tens of millions of patients around the world and have not been shown to cause tumors. The magnetic energy used in a full course of TMS Therapy is a small fraction of just one brain scan with an MRI.
No, the NeuroStar TMS Therapy system was systematically evaluated for its effects on memory. Clinical trials demonstrated that NeuroStar TMS Therapy does not result in any negative effects on memory or concentration.
No, the most common side effect related to treatment was scalp discomfort during treatment sessions. This side effect was generally mild to moderate, and occurred less frequently after the first week of treatment.
If necessary, you can treat this discomfort with an over-the-counter analgesic. If these side effects persist, your doctor can temporarily reduce the strength of the magnetic field pulses being administered in order to make treatment more comfortable.
Less than 5% of patients treated with NeuroStar TMS Therapy discontinued treatment due to side effects.
NeuroStar TMS is the only TMS system with the durability of its effects established over 12 months. In a clinical trial, 2 out of 3 patients who had either responded to treatment or completely remitted their depression symptoms reported 12 months later that they remained at the level they were at the end of the trial. Additionally, after the trial, only 1 in 3 patients needed to return for ‘maintenance’ TMS sessions.
Yes. In clinical trials, NeuroStar TMS Therapy was safely administered with and without other antidepressant medications.
No, the NeuroStar TMS Therapy system is the first TMS device to be cleared by the U.S. Food and Drug Administration (FDA) for the treatment of major depression.
The NeuroStar TMS Therapy system is also the first TMS device to have been evaluated in a large, multicenter, controlled clinical trial, as well as the only TMS system with the durability of its effects over 12 months established.