TMS for Migraine: The Single-Pulse Device

TMS for migraine is a different treatment from TMS for depression. It uses a small, hand-held device that the patient holds against the back of the head and fires at home, delivering a few single magnetic pulses rather than a clinic course of thousands. This single-pulse TMS (sTMS) is FDA-cleared: first in 2013 for the acute treatment of pain in migraine with aura, and since 2019 for both acute and preventive treatment of migraine in adults and adolescents aged 12 and older.

The evidence is reasonable but limited: one sham-controlled trial for acute treatment and an open-label study for prevention. It is a niche option, usually considered by a headache specialist when medications are not working or not tolerated.

The device and its clearances

The cleared migraine TMS devices described here all come from one manufacturer, eNeura, and sit under their own FDA regulation, "transcranial magnetic stimulator for headache", separate from the depression rule.

Like every TMS device, these are FDA-cleared or De Novo-authorized Class II devices, not "FDA-approved". The broader regulatory story is in a short history of TMS.

How it is used at home

The FDA summary for the sTMS mini describes a portable device that "delivers a brief single pulse of magnetic energy at 0.9 Tesla to the back of the head" to induce a current in the occipital cortex, the visual area of the brain. It is prescription-only, treatments are self-administered at home or elsewhere, and the device runs on a SIM chip that a physician prescribes for a set number of months.

The number of pulses has varied by label and study:

• The original Cerena treatment consisted of two pulses, and its 2013 summary said use should not exceed one treatment per 24 hours.
• In the ESPOUSE prevention study, patients used four pulses twice daily for prevention and three pulses, repeated up to three times, for each attack.

Patients should follow the instructions supplied with their own prescribed device rather than any study protocol.

The evidence for acute treatment

The pivotal trial, published in Lancet Neurology in 2010, randomized 201 adults with migraine with aura at 18 US centers to sTMS or a sham device and asked them to treat up to three attacks over 3 months. Among the 164 who treated at least one attack, 39% were pain-free at 2 hours with sTMS versus 22% with sham, a 17-point gain. Pain freedom was also more frequently sustained at 24 and 48 hours.

FDA's review attached limits that patients rarely hear about. The 2013 De Novo summary states that the device "has not been shown to be effective when treating during the aura phase", has not been shown to relieve the nausea, light sensitivity and sound sensitivity that accompany migraine, and has not been shown safe or effective for cluster headache or chronic migraine.

The evidence for prevention

The preventive indication rests mainly on ESPOUSE, a multicenter, open-label, single-arm study published in 2018. In the 132 patients in the main analysis, monthly headache days fell by an average of 2.75 from a baseline of 9.06, and 46% had at least a 50% reduction. The comparison was against a statistically derived placebo estimate, not a sham device, so the true placebo-adjusted benefit is uncertain. The most common side effects were lightheadedness (3.7%), tingling (3.2%) and tinnitus (3.2%), with no serious adverse events.

Who it may suit

Because the evidence base is narrow, the device fits best where the data are strongest and other options are limited:

• Migraine with aura, the population in the pivotal sham-controlled trial.
• People who cannot take, do not tolerate or overuse acute migraine medications, under the care of a clinician who can rule out medication-overuse headache first.
• Adolescents 12 and older, who are within the 2019 label, with the caveat that the pivotal acute trial enrolled only adults (aged 18 to 68) and the 2019 clearance was a labeling expansion.

The 2013 summary noted that safety and effectiveness had not been established in pregnant women, children under 18 or adults over 65 (the age floor was later lowered to 12 by the 2019 label), so those groups need an individual discussion with a specialist.

How sTMS differs from rTMS for depression

The proposed mechanism is that a pulse to the occipital cortex disrupts the abnormal wave of cortical activity associated with migraine aura, though this is not fully understood. Either way, it is a different mechanism from the repeated stimulation used to reshape mood circuits, described in how TMS works. A course of depression TMS should not be expected to treat migraine, and the migraine device is not a depression treatment.

Who should not use it

The 2013 FDA summary lists people who should not use the device, including those with:

• metal, conductive material or metal-containing implants in the head, neck or upper body that are attracted by a magnet;
• a cardiac pacemaker, deep brain stimulator, vagus nerve stimulator, spinal cord stimulator, implanted defibrillator or any active implanted medical device;
• suspected or diagnosed epilepsy, or a personal or family history of seizures;
• headaches due to underlying disease or trauma, or medication-overuse headache.

Any new, changed or "worst ever" headache needs medical evaluation before a home device is considered. Seizure risk with clinic TMS is covered in TMS safety and seizure risk.

Migraine, depression and getting the right care

Some patients have both migraine and depression and ask whether one TMS course can address both. The answer is no: they use different devices, targets and schedules. Depression that has not responded to medication may be an indication for clinic-based TMS in its own right, assessed on its own merits; see the TMS therapy page for more on TMS in psychiatric care.

Insurance coverage for migraine TMS is limited. EmblemHealth, for example, lists TMS for migraine among indications it does not cover, and UnitedHealthcare's commercial policy classes TMS for non-behavioral conditions as unproven. Ask a headache specialist whether a device is currently available, how it is supplied, and what it would cost. A wider look at headache care is in an integrative approach to treating headaches; for pain conditions treated with clinic rTMS, see TMS for chronic pain and fibromyalgia; and for the rest of the evidence, the TMS physician's guide.

Frequently asked questions

Is TMS FDA-approved for migraine?

Single-pulse TMS devices from eNeura are FDA-cleared (not approved, which is a different pathway). Current labels cover acute and preventive treatment of migraine in people aged 12 and older.

Can I get migraine TMS at a depression TMS clinic?

Migraine sTMS is a prescribed home device, usually through a neurologist or headache specialist. A depression TMS clinic uses different equipment and protocols.

Does the migraine device hurt?

Each treatment is a few brief pulses. In the prevention study, the most common side effects were lightheadedness, tingling and tinnitus, each in under 4% of patients, and there were no serious adverse events.

Does it help the nausea and light sensitivity of migraine?

FDA's 2013 summary states the device was not shown to relieve those associated symptoms; the trial's main benefit was freedom from pain at 2 hours.

Can people with epilepsy use it?

No. The FDA summary says the device should not be used by people with suspected or diagnosed epilepsy or a personal or family history of seizures.

Sources

1. De Novo Classification Request DEN130022 and De Novo Summary (K130556): Cerena Transcranial Magnetic Stimulator. U.S. FDA, 2013. accessdata.fda.gov
2. 510(k) K140094 (SpringTMS) and K161663 (sTMS mini). U.S. FDA, 2016. accessdata.fda.gov
3. 510(k) K182976 (SpringTMS) and K230358 (SAVI Dual Migraine Therapy). U.S. FDA, 2019. accessdata.fda.gov
4. 21 CFR 882.5808 Transcranial magnetic stimulator for headache. eCFR, 2026. ecfr.gov
5. Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial. Lancet Neurology, 2010. pubmed.ncbi.nlm.nih.gov
6. A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study). Cephalalgia, 2018. pubmed.ncbi.nlm.nih.gov
7. FDA De Novo Summary K130556 (Cerena) and 510(k) summary K161663 (sTMS mini), device description, use limits and contraindications. U.S. FDA, 2016. accessdata.fda.gov
8. 510(k) Premarket Notification, Premarket Approval and De Novo pathway pages. U.S. FDA, 2026. fda.gov
9. K231926 510(k) Summary: NeuroStar Advanced Therapy System. U.S. FDA, 2024. accessdata.fda.gov
10. 510(k) K173620: MagVita TMS Therapy System w/Theta Burst Stimulation. U.S. FDA, 2018. accessdata.fda.gov
11. K220177 510(k) Summary: Magnus Neuromodulation System with SAINT Technology. U.S. FDA, 2022. accessdata.fda.gov
12. EmblemHealth Medical Technology Database. EmblemHealth, 2025. emblemhealth.com

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