A Short History of TMS: From 1985 to Accelerated Protocols

Modern TMS began in 1985, when Anthony Barker and colleagues reported in The Lancet that a magnetic pulse could stimulate the human motor cortex through the intact skull. Within ten years researchers were testing daily prefrontal stimulation for depression, and in October 2008 FDA authorized the first TMS system for major depression. Since then the field has moved from one coil and one 37.5-minute protocol to deep TMS, 3-minute theta-burst sessions, accelerated courses and labels for teenagers.

This page traces that path, with the regulatory milestones dated from FDA records and the research milestones from the original papers. It is a history, not an endorsement of any device; for how the technology works now, see how TMS works.

Timeline at a glance

1985 to 1996: from motor cortex to mood

Before 1985, stimulating the human cortex generally meant applying electricity, either directly during surgery or through scalp electrodes. Barker's group used a pulsed magnetic field instead, which passes through the skull and induces current in the cortex beneath. Their 1985 Lancet report, titled "Non-invasive magnetic stimulation of human motor cortex", introduced the technique that later TMS devices build on. Measuring the muscle twitch produced by a motor-cortex pulse is still how every treatment course sets its dose today; see motor threshold and dosing.

Two discoveries in the early 1990s turned a diagnostic tool into a possible treatment. First, researchers found that trains of rapid pulses, rather than single pulses, produced effects that outlasted the stimulation, a short period of increased cortical excitability. Second, lesion and imaging studies suggested that left prefrontal dysfunction was linked to depression.

In 1995 Mark George and colleagues reported a pilot of daily left prefrontal rTMS in six highly medication-resistant inpatients. Hamilton depression scores fell from 23.8 to 17.5 on average, and one patient remitted for the first time in 3 years. In 1996, Alvaro Pascual-Leone's group in Valencia published a randomized, sham-controlled crossover study in 17 patients with medication-resistant psychotic depression; left DLPFC stimulation produced a significant improvement, from 25.2 to 13.8 on the Hamilton scale, and 11 of the 17 improved markedly for about 2 weeks. Both studies were small, but they fixed the target the field still uses.

2007 to 2011: the pivotal trials and FDA authorization

The question through the early 2000s was whether TMS beat a convincing placebo in a large trial. The multisite O'Reardon trial randomized 301 medication-free outpatients to active or sham TMS at multiple sites. Its primary endpoint at week 4 was positive only after a post hoc correction for baseline differences, though active TMS was superior on other Hamilton measures at weeks 4 and 6.

FDA's first marketing authorization for TMS came on October 7, 2008, through the De Novo pathway for the NeuroStar system, after an earlier 510(k) submission was found not substantially equivalent. The original indication was narrow: adults who had not improved on one prior antidepressant at an adequate dose and duration in the current episode. By 2016 the label had been broadened to adults who had not improved on prior antidepressant medication, without the "one prior" wording.

The independent confirmation came in 2010. The NIMH-funded OPT-TMS trial randomized 199 antidepressant-free patients at 4 university sites and used an active sham with scalp electrodes to mimic the sensation. Remission was 14.1% with active TMS vs 5.1% with sham. The modest absolute numbers are a reminder that TMS has always been one option among several, and the 2010 APA guideline listed it as something that "could also be considered" for depression not helped by medication.

In 2011, FDA codified rTMS systems for depression as Class II devices with special controls. This was a classification of a new device type, not a "reclassification". It is why TMS devices are described as FDA-cleared or De Novo-granted rather than FDA-approved, a distinction explained in Is TMS FDA-approved?

2013 to 2020: new coils, new conditions

The first major hardware change was the H-coil. Its developers reported in 2005 that it could activate the motor cortex from 5.5 cm away, compared with 2 cm for a figure-8 coil. After a multicenter sham-controlled trial, BrainsWay Deep TMS was cleared for adult depression in January 2013. In December of the same year, the Cerena device became the first TMS product authorized, through De Novo, for acute treatment of pain from migraine with aura. The deep TMS vs standard TMS comparison covers what the different coil means in practice.

Deep TMS then expanded beyond depression: a De Novo grant for obsessive-compulsive disorder in August 2018, as an adjunct, and a clearance as an aid to short-term smoking cessation in 2020.

2018: theta burst shortens the session

Theta-burst stimulation came out of basic physiology. In 2005, Huang and colleagues showed that bursts of pulses patterned on the brain's theta rhythm produced a "long-lasting, and powerful effect" on motor cortex after 20 to 190 seconds of stimulation. The Canadian THREE-D trial then randomized 414 adults with treatment-resistant depression to standard 10 Hz rTMS or intermittent theta burst (iTBS) and found iTBS non-inferior. FDA cleared the first iTBS protocol in August 2018, with a session listed at 3 minutes and 9 seconds. Details are in the theta burst guide.

2022 to 2026: accelerated courses, teenagers and new indications

The next idea was compressing the course. Stanford's SAINT protocol, now called Stanford Neuromodulation Therapy, delivers 10 iTBS sessions a day for 5 days to a target chosen from each patient's functional MRI. It was cleared as a 510(k) in September 2022. A 2025 consensus noted that it "only became commercially available in 2024". The SAINT guide explains what it is and is not.

SAINT is no longer the only cleared accelerated option. BrainsWay's accelerated deep TMS protocol was cleared in September 2025, and a MagVenture clearance in May 2026 covers schedules of 2 to 10 sessions a day. Single-day protocols combined with medications have not been cleared; see accelerated TMS.

Age limits also changed. In March 2024 NeuroStar received the first adolescent label, for adjunctive treatment of major depression at ages 15 to 21. By August 2026 at least seven systems carried a similar label. That label rests on registry data; the one large sham-controlled adolescent trial was negative, which parents should know. For a family-oriented explanation, see TMS for teens and young adults.

Two further milestones arrived in 2026: the first TMS-based clearance for PTSD, as an adjunct, in June, and a growing list of adolescent and OCD labels across manufacturers.

Professional opinion moved alongside the devices. The Canadian CANMAT 2023 guideline rated rTMS a first-line treatment for treatment-resistant depression, and the American Psychiatric Association's 2024 position statement called TMS "a safe and effective evidence-based medical treatment when administered by TMS-trained psychiatrists for appropriately selected patients."

What the history teaches

• Each step forward was built on small studies first. Large, independent confirmations often came years later, and some newer protocols are still waiting for them.
• Faster is not automatically better. Shorter sessions and accelerated courses are real advances in convenience, but their long-term durability is still being studied.
• An FDA clearance describes a device and indication, not proof that a treatment beats every alternative. The landmark trials review summarizes what each study actually showed.

TMS has never been a treatment for an emergency. If you are thinking about suicide or are in crisis, call or text 988 (the 988 Suicide & Crisis Lifeline) or go to the nearest emergency room.

More guides are in the TMS guide, and the TMS therapy page describes TMS as part of psychiatric care.

Frequently asked questions

Who invented TMS?

Anthony Barker, Reza Jalinous and Ian Freeston reported the first non-invasive magnetic stimulation of the human motor cortex in The Lancet in 1985. Its use for depression was developed in the 1990s by several groups, including Mark George's group in the United States and Alvaro Pascual-Leone's group in Spain.

When was TMS first FDA-cleared for depression?

FDA authorized the NeuroStar system through the De Novo pathway on October 7, 2008, for adults with major depression who had not improved on one prior antidepressant in the current episode.

Is TMS a new or experimental treatment?

Standard TMS for adult depression has been FDA-authorized since 2008 (through De Novo, with later 510(k) clearances) and is rated first-line for treatment-resistant depression by the CANMAT 2023 guideline. Some newer variations, such as single-day protocols combined with medications, are still investigational.

What changed with theta burst stimulation?

Theta burst delivers patterned pulses that shorten a session to about 3 minutes. The 2018 THREE-D trial found it non-inferior to standard 10 Hz rTMS, and the first theta-burst protocol was cleared that August.

When did TMS become available for teenagers?

The first adolescent label, for adjunctive treatment of major depression at ages 15 to 21, was cleared in March 2024. Several other systems have since received similar labels.

Sources

1. Non-invasive magnetic stimulation of human motor cortex. The Lancet, 1985. pubmed.ncbi.nlm.nih.gov
2. Responses to rapid-rate transcranial magnetic stimulation of the human motor cortex. Brain, 1994. pubmed.ncbi.nlm.nih.gov
3. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. NeuroReport, 1995. pubmed.ncbi.nlm.nih.gov
4. Rapid-rate transcranial magnetic stimulation of left dorsolateral prefrontal cortex in drug-resistant depression. The Lancet, 1996. pubmed.ncbi.nlm.nih.gov
5. Transcranial magnetic stimulation of deep brain regions: evidence for efficacy of the H-coil. Clinical Neurophysiology, 2005. pubmed.ncbi.nlm.nih.gov
6. De Novo Classification Request DEN070003 (NeuroStar TMS System). U.S. FDA, 2008. accessdata.fda.gov
7. 510(k) K083538: NeuroStar Model 1.1. U.S. FDA, 2008. accessdata.fda.gov
8. 510(k) K160703: NeuroStar TMS Therapy System. U.S. FDA, 2016. accessdata.fda.gov
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11. Practice Guideline for the Treatment of Patients With Major Depressive Disorder, Third Edition. American Psychiatric Association, 2010. psychiatryonline.org
12. 21 CFR 882.5805 Repetitive transcranial magnetic stimulation system. eCFR, 2026. ecfr.gov
13. Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation Systems; Availability. Federal Register, 2011. govinfo.gov
14. 510(k) K122288: BrainsWay Deep TMS System. U.S. FDA, 2013. accessdata.fda.gov
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16. De Novo Classification Request DEN170078 (BrainsWay Deep TMS for OCD). U.S. FDA, 2018. accessdata.fda.gov
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18. Theta burst stimulation of the human motor cortex. Neuron, 2005. pubmed.ncbi.nlm.nih.gov
19. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. The Lancet, 2018. pubmed.ncbi.nlm.nih.gov
20. K173620 510(k) Summary: MagVita TMS Therapy System w/Theta Burst Stimulation. U.S. FDA, 2018. accessdata.fda.gov
21. K220177 510(k) Summary: Magnus Neuromodulation System with SAINT Technology. U.S. FDA, 2022. accessdata.fda.gov
22. Consensus review and considerations on TMS to treat depression: A comprehensive update endorsed by the National Network of Depression Centers, the Clinical TMS Society, and the International Federation of Clinical Neurophysiology. Clinical Neurophysiology, 2025. doi.org
23. K251449 510(k) Summary: BrainsWay accelerated Deep TMS. U.S. FDA, 2025. accessdata.fda.gov
24. K260189 510(k) Summary: MagVenture Accelerated TMS (aTMS) Therapy System. U.S. FDA, 2026. accessdata.fda.gov
25. Clinical TMS Society's Statement on Level of Evidence for Single-Day TMS combined with Medications. Clinical TMS Society, 2025. clinicaltmssociety.org
26. K231926 510(k) Summary: NeuroStar Advanced Therapy System (adolescent indication). U.S. FDA, 2024. accessdata.fda.gov
27. 510(k) Premarket Notification database (adolescent MDD clearances, 2024-2026). U.S. FDA, 2026. accessdata.fda.gov
28. Left prefrontal transcranial magnetic stimulation for treatment-resistant depression in adolescents: a double-blind, randomized, sham-controlled trial. Neuropsychopharmacology, 2021. pubmed.ncbi.nlm.nih.gov
29. 510(k) K260402: MeRT System for PTSD. U.S. FDA, 2026. accessdata.fda.gov
30. Canadian Network for Mood and Anxiety Treatments (CANMAT) 2023 Update on Clinical Guidelines for Management of Major Depressive Disorder in Adults. Canadian Journal of Psychiatry, 2024. pmc.ncbi.nlm.nih.gov
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32. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial. World Psychiatry, 2015. pmc.ncbi.nlm.nih.gov

Educational information, not medical advice. Whether TMS or any treatment fits you is a decision to make with a psychiatrist who knows your history.