FDA Approves Device to Treat Migraines

The U.S. Food and Drug Administration (FDA) has approved the first medical device used as a preventative to ward off migraine headaches, an electrical nerve stimulator used before the onset of pain.

The device, a plastic headband that emits low electrical energy to stimulate nerves in the head, is called Cefaly and made by Cephaly Technology of Liege, Belgium. Christy Foreman, director of the office of device evaluation at the FDA’s medical device center, said the battery-powered device “may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.”

Michael Solomita, vice president of the device’s North American distributor, Roxon Medi-Tech Ltd. of Canada, said the device is sold at retail for the equivalent of about $300 U.S. in Canada, where it was approved previously. He told The Wall Street Journal it is likely to will cost approximately the same in the United States.

Peggy Mason, a University of Chicago professor of neurobiology, said similar devices previously have been available for other types of pain. The electrical stimulation they emit, she claimed, provides a kind of “counterirritant” to the nerves and can forestall more serious pain, the newspaper reported. Such nerve stimulation providers are known as TENS devices, for Transcutaneous Electrical Nerve Stimulation. The principle has been used in medicines for decades. The Cefaly device is placed on the forehead and worn like a pair of eyeglasses, resting on the ears.

Migraines feature powerful pulsing or throbbing pain from one portion of the head, and also can include nausea, vomiting and sensitivity to light and sound. They can typically last from four to 72 hours if not treated. The National Institutes of Health has estimated migraines can affect roughly 10 percent of the people in the world and that the headaches are about three times more common among women than men.

The Cefaly product is sold by prescription; it applies an electric current to the skin and underlying bodily tissues. The device works on the nerve that transmits migraine pain, a branched structure known as the trigeminal nerve. The FDA said a patient typically will feel a tingling or massaging sensation during therapy, which should be used once daily for 20 minutes.

A clinical study conducted in Belgium involved 67 patients randomly assigned to the treatment or to placebo therapy. Patients with the treatment experienced an average of 4.88 days of migraines monthly, compared with 6.94 days monthly experienced before treatment. There was no significant difference in migraine days among people with the placebo device before and after the study, researchers reported in the journal Neurology.