BOSTON—A novel, portable handheld device that delivers brief magnetic pulses can safely and effectively reduce pain onset in patients who have migraine with aura, according to data presented by Robert B. Lipton, MD, and colleagues at the 50th Annual Scientific Meeting of the American Headache Society.
“Migraine is not a one-size-fits-all condition, and treatment has to be individualized,” said Dr. Lipton, who is a Professor in the Departments of Neurology and Epidemiology and Population Health and Director of the Montefiore Headache Center at Albert Einstein College of Medicine, Bronx, New York. “Although drug treatment benefits many patients, one sometimes has to try several medications or combine drugs. [Transcranial magnetic stimulation (TMS)] can be beneficial for [patients] who do not respond to medication, have contraindications or side effects to medication, or prefer nondrug treatment.”
A Noninvasive, Painless Treatment
The double-blind sham-controlled study of 164 outpatients (mean age, 39; 79% female) was conducted at the Ohio State University Medical Center in Columbus. Participants had visual aura during at least 30% of migraine episodes, followed by moderate or severe headache 90% of the time. Patients were randomized to TMS or sham therapy during the early stages of migraine with aura. The noninvasive and painless TMS treatment delivers pulses of a 1-Tesla magnetic field during the aura phase of migraine. It has been tested successfully in previous studies using a large, tabletop TMS device.
For this study, however, to expedite treatment at home, a portable handheld version was developed. While experiencing aura, patients applied the device twice per migraine episode; they then electronically recorded pain intensity and symptoms at time of treatment and various posttreatment stages: at 30 minutes and at one, two, 24, and 48 hours. The primary end point was no pain at two hours for the first treated episode.
TMS Is Associated With Less Pain Posttreatment
TMS was associated with significantly higher rates of no pain at two hours posttreatment (39%), compared with sham therapy (22%), yielding a 17.1% risk reduction. As many as three episodes within three months were treated.
Other migraine symptoms, such as nausea, photophobia, and phonophobia, were measured at two hours and had similar or lower rates in TMS-treated patients than in those receiving sham therapy. Additionally, adverse events and number of patients experiencing adverse events were similar between the two groups. No device-related serious adverse events were reported.
Can TMS Be Useful in Other Patient Populations?
According to coauthor Yousef Mohammad, MD, MSC, the positive safety results and lack of TMS-associated adverse events within this and other studies “sets the stage for future studies in migraines without aura.” Plans are also under way to study TMS in patients with chronic migraine, noted Dr. Mohammad, who is an Assistant Professor of Neurology at the Ohio State University Medical Center.
“These are early days in the development of the treatment, and much more research must be done so that benefits can be optimized,” Dr. Lipton concluded. “TMS treatment may be useful in other patient populations or for prevention, but that remains to be determined.”
—Taryn Fort