WASHINGTON (March 11, 2014) The U.S. Food and Drug Administration says it has approved a nerve-stimulating headband as the first medical device to prevent migraine headaches.
The Cefaly device is a battery-powered plastic band worn across the forehead that emits an electric current to stimulate nerves associated with migraine pain.
It’s designed to be used no more than 20 minutes a day by patients who are 18 years and older.
A 67-person study reviewed by the FDA showed patients using the device experienced fewer migraines per month than patients using a placebo device.
The Cefaly did not completely eliminate migraine headaches or reduce the intensity of migraines that occurred.
About 53 percent of 2,313 patients in a separate study said they were satisfied with the device and willing to purchase it for future use.