LOS ANGELES – A handheld transcranial magnetic stimulation device delivered mixed results in a small study of patients with migraine headaches, Dr. Yousef Mohammad reported at the annual meeting of the American Headache Society.
Numerically, the device extinguished more migraines within 2 hours than did a sham device that made an audible buzz but delivered no magnetic pulses to the head, said Dr. Mohammad.
Among 23 patients who received two brief magnetic pulses, 30 seconds apart, 17 (74%) were headache-free or reported only minimal pain at 2 hours, compared with 9 of 20 patients (45%) randomized to sham device treatment. But perhaps because of the small sample size, the difference was not statistically significant, said Dr. Mohammad, a member of the neurology faculty at Ohio State University, Columbus.
The transcranial magnetic stimulation (TMS) treatment significantly reduced photophobia and phonophobia at 2 hours, compared with placebo, and more patients receiving TMS treatments rated the effectiveness as “excellent” or “very good.”
Statistical trends were seen in the ability of TMS to reduce nausea and restore patients to normal functioning at 2 hours post treatment, although these end points also failed to reach statistical significance, he reported. The only adverse event found was left-sided numbness reported by one patient, but this symptom developed before administration of TMS.
Dr. Mohammad pointed out that the study design called for patients to receive their TMS or sham treatments at a hospital, leading to delays that potentially outlasted the device's potential to abort a migraine.
Patients with a history of migraine with aura were instructed to report to preselected hospitals immediately upon experiencing an aura. The TMS device or the sham device was placed either over the occipital region, if only aura was present, or over the area of maximum pain, if the headache had begun.
Efforts are underway to develop a user-friendly portable device that patients could use at home at the first sign of an impending migraine. This version of the device will be put to the test in a large, multicenter trial that will also use sham devices as placebo, said Dr. Mohammad, who disclosed that he is an investigator for Neuralieve Inc., the commercial sponsor of the study.