BOSTON, June 27 -- For patients who get migraine with aura, a hand-held magnetic device about the size and shape of a hairdryer can zap the pain before it starts, a researcher said here.Used at the aura stage, the transcranial magnetic stimulation device was nearly twice as likely as a sham treatment to reduce the incidence of a full migraine headache, according to Yousef Mohammad, M.D., of Ohio State University Medical Center in Columbus.
The industry-sponsored phase III randomized double-blind trial follows earlier research that showed the magnetic stimulation process was effective when used in a hospital setting, Dr. Mohammad told attendees at the American Headache Society meeting.
Dr. Mohammad said the device -- which sends two one-Tesla magnetic pulses into the back of the head -- is also safe, with no serious adverse events attributed to it.
"It feels like a slight pressure at the back of the head and that's it," he said.
The theory is that the magnetic pulses interrupt a process called cortical spreading depression, now thought to be the underlying mechanism for migraine with aura, he said.
A similar technique is being tested in patients with depression.
For this study, patients were randomized to a device that emitted the magnetic pulses or to a sham machine. They were told to use the device when the migraine aura began and to record their pain intensity and symptoms at time of treatment and again 30 minutes, one hour, two hours, 24 hours, and 48 hours later.
The intent-to-treat population of 164 patients had a mean age of 39 and 79% were women. Most patients treated themselves while still pain-free or with mild pain (31% and 40%, respectively) but 23% had moderate pain and 6% said their pain was already severe before they used the machine.
The primary endpoint of the study was absence of pain at the two-hour mark, Dr. Mohammad said, where 39% of the active treatment group had no pain, compared with 20% of those using the sham machine.
The difference was significant at P<0.018, he said.
Rates of symptoms such as nausea, photophobia, and phonophobia in the active treatment group were equal to or lower than those seen in the group using the sham machine, according to Dr. Mohammad.
Because of the lack of adverse events and the previously established safety of the transcranial magnetic stimulation device, he said, "this is a promising treatment for migraines with aura."
He added that it also sets the stage for research in migraines without aura.
The device is not yet approved by the FDA, Dr. Mohammad said, but the okay could come within the next six months, based on the current trial.
He added that medical treatments for migraine with aura work in only about half of all patients and some of those can't tolerate the drugs. "There is a definite need for alternatives," Dr. Mohammad said.
The study was supported by NeuraLieve Inc., of Sunnyvale, Ca., manufacturer of the device. Dr. Mohammad serves on the company's medical advisory board
Primary source: AHS Meeting
Secondary Source: medpageTODAY®
Source reference:
Lipton RB, et al “Transcranial Magnetic Stimulation (TMS) using a portable device is effective for the acute treatment of migraine with aura: Results of a double-blind, sham controlled, randomized study” AHS Meeting 2008; LB abstract 450026.
Source reference:
Lipton RB, et al “Transcranial Magnetic Stimulation (TMS) using a portable device is effective for the acute treatment of migraine with aura: Results of a double-blind, sham controlled, randomized study” AHS Meeting 2008; LB abstract 450026.
