The FDA cleared an expanded indication for single-pulse transcranial magnetic stimulation devices to treat acute migraine attacks regardless of aura status. The previous clearance, in place since 2013, was limited to acute migraine with aura — a subset representing roughly a third of migraine patients.
The expansion was based on a 410-patient sham-controlled trial in which single-pulse TMS achieved pain freedom at two hours in 39% of patients versus 21% with sham. Most patients applied the device to the back of the head within an hour of attack onset. No serious adverse events were reported.
The cleared devices are handheld and designed for at-home use under prescription. They do not require clinic visits and are distinct from repetitive TMS used for depression. List price for the device remains in the $400-$500 per month rental range, with mixed insurance coverage.
The expansion is expected to broaden patient access significantly, since aura status is often difficult for patients to characterize and excludes many who would otherwise benefit. The American Headache Society released updated treatment guidelines this month incorporating the new indication.
Source
Reporting based on coverage from FDA Newsroom. This article is editorial summary intended for general information; it is not medical advice.