SAINT® TMS Side Effects, Long-Term Effects & Safety Risks

The most common side effects of SAINT® TMS are headache and scalp discomfort at the stimulation site, which are usually mild to moderate and tend to ease over the first day or two (Cole et al., Am J Psychiatry 2022;179(2):132–141). Facial muscle twitching during pulses is common and harmless. Some people report fatigue or anxiety during the treatment week. The most serious risk — seizure — is rare with proper screening. SAINT® does not cause the memory problems associated with ECT, and there is no anesthesia or sedation.

People with non-removable magnetic-sensitive metal in or near the head, certain implanted devices, or who cannot safely have an MRI should not receive SAINT®. If you are in crisis or having thoughts of suicide, call or text 988. The sections below go deeper into each risk, the long-term evidence, and the contraindications.

SAINT® is FDA-cleared for the treatment of major depressive disorder (MDD) in adults whose depression has not improved enough on prior antidepressant medication. The most commonly reported side effects in the clinical trial were headache and scalp discomfort, which were mild to moderate and tended to decrease over the first day or two of treatment (Cole et al., Am J Psychiatry 2022;179(2):132–141). Individual results may vary.

The most serious risk associated with TMS is seizure, which is rare. No evidence from decades of TMS research shows that the magnetic pulses used in TMS damage brain tissue. SAINT® does not cause the memory problems, sedation, or anesthesia-related risks associated with some other brain-based treatments. People with non-removable magnetic-sensitive metal in or near the head, certain implanted devices, or increased intracranial pressure should not receive SAINT®.

If you are in crisis or having thoughts of suicide, call or text 988. The 988 Suicide and Crisis Lifeline is available 24/7.

The most commonly reported side effects of SAINT® and TMS generally are headache, scalp discomfort or pain at the stimulation site, and facial muscle twitching during pulses. In the THREE-D trial — a large randomized study of standard TMS — headache was reported by about two-thirds of participants (Blumberger et al., Lancet 2018;391(10131):1683–1692). In the 2022 SAINT® randomized trial, headache and scalp discomfort were the most frequently reported adverse events, and they were generally mild to moderate in severity (Cole et al., Am J Psychiatry 2022;179(2):132–141). Individual results may vary.

These effects tend to decrease over the first day or two of treatment as the scalp adjusts to stimulation. Over-the-counter pain relievers such as acetaminophen or ibuprofen are often sufficient for headaches. The treatment team can adjust coil position or reduce stimulation intensity if discomfort persists.

Facial muscle twitching during pulses is common and harmless — it happens because the magnetic field stimulates the nerves that control facial muscles near the treatment site. It stops when stimulation stops. Most people find it surprising at first but not painful.

Seizure is the most serious risk associated with TMS. With standard TMS parameters and proper screening, the risk of seizure is estimated at less than 0.1% of sessions [VERIFY — exact rate for accelerated protocols]. A history of seizures requires careful evaluation and may rule out treatment. The screening process is designed to identify people at elevated seizure risk before treatment begins.

TMS can also, rarely, trigger manic symptoms in people with bipolar disorder. This is why screening for bipolar disorder is part of the evaluation before SAINT®. SAINT® is not FDA-cleared for bipolar depression.

As with any depression treatment, there is a risk of worsening depression or suicidal thoughts. The 2022 SAINT® trial monitored participants for these risks, and the treatment team checks in with you throughout the week. If you notice your mood getting worse, tell the team immediately. If you are in crisis, call or text 988.

Because accelerated protocols deliver many more pulses per day and have been studied in far fewer people than conventional TMS, rare risks are less well characterized. This is a limitation of the current evidence that your psychiatrist can discuss with you.

Long-term safety data for accelerated TMS protocols like SAINT® are still accumulating. The 2022 randomized trial tracked outcomes over several weeks of follow-up (Cole et al., Am J Psychiatry 2022;179(2):132–141). Individual results may vary, and some people may benefit from additional treatment courses over time.

Standard TMS has been studied for over 20 years, and no cumulative toxicity, delayed injury, or progressive harm has been identified in the research literature. The magnetic pulses used in TMS do not accumulate in the body or cause cumulative damage with repeated exposure.

What the evidence does not yet show is how SAINT®-specific outcomes hold up over months and years in large, diverse populations. The published SAINT® data come from relatively small trials. Your psychiatrist can discuss what follow-up and monitoring look like after the treatment week, and what the current evidence does and does not cover for your individual situation.

If you have questions about long-term effects, talk to your psychiatrist or check if SAINT® is a fit.

No. There is no evidence that TMS damages brain tissue. TMS uses focused magnetic pulses to stimulate neurons in a specific brain region — it does not create lesions, destroy tissue, or cause structural injury. Brain imaging studies of TMS patients have not identified brain damage as a risk.

This is a common concern because TMS involves direct stimulation of the brain. But the magnetic field in TMS is the same type used in MRI scanners — it is non-ionizing, meaning it does not carry the radiation risks associated with X-rays or CT scans. The pulses temporarily increase neural activity in the target region; they do not permanently alter brain structure.

SAINT® uses the same magnetic stimulation technology as standard TMS, delivered in an accelerated schedule (10 sessions per day over 5 days). The difference is the schedule and the personalized targeting — not the fundamental safety profile of the magnetic pulses themselves.

Some people worry that the accelerated schedule — 50 sessions in one week — could overwhelm the brain. The 2022 trial did not show evidence of harm from the accelerated schedule, though the trial was small and long-term data are still accumulating (Cole et al., Am J Psychiatry 2022;179(2):132–141). Individual results may vary. This is something to discuss with your psychiatrist during your consultation.

People with non-removable magnetic-sensitive metal in or near the head should not receive SAINT®. This includes cochlear implants, aneurysm clips, certain stents, and other ferromagnetic implants. The magnetic field could move or heat the metal, causing injury. Implanted electronic stimulators — such as deep brain stimulation devices — are also a contraindication.

People who cannot safely have an MRI are not candidates for SAINT®, because every SAINT® patient requires a brain scan before treatment. Does SAINT® require an MRI?

SAINT® is not FDA-cleared for bipolar depression, PTSD, anxiety disorders alone, OCD, concussion, or any condition other than major depressive disorder in adults. NWCOA treats adults 22 and older. SAINT® is not for anyone under 18.

A thorough psychiatric evaluation at NWCOA reviews your medical history, medications, and any implants before recommending SAINT®. Check your eligibility or learn about treatment-resistant depression.

During the five-day SAINT® week, the treatment team monitors you at each session. You sit awake in a chair while a coil on your scalp delivers magnetic pulses. The team checks in on how you're feeling, adjusts intensity if needed, and tracks your mood throughout the week.

Unlike SPRAVATO® (esketamine), SAINT® does not require a post-session monitoring period — you can generally drive yourself to and from the clinic and return to your day after each session. There is no sedation and no anesthesia.

The team also watches for any signs of worsening mood or new symptoms. If you feel worse, tell the team right away. They can pause treatment, adjust the plan, or bring in a psychiatric review. As with any depression treatment, there is a risk of worsening depression or suicidal thoughts, and the team takes any change seriously.

If you are in crisis, call or text 988. The 988 Suicide and Crisis Lifeline is available 24/7, free and confidential.

SAINT® does not cause the memory problems that can follow ECT (electroconvulsive therapy). It does not use anesthesia or induce a seizure. It does not cause the weight gain, sexual dysfunction, nausea, or insomnia that are common side effects of many antidepressant medications.

SAINT® does not require any recovery time after sessions — patients can drive and resume normal activities. It does not involve any chemical entering the body. These differences are part of why some people who haven't tolerated medication side effects consider SAINT®.

Compare SAINT® to other treatments or see what SAINT® feels like.