Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said this is the first transcutaneous -- applied across the skin -- electrical nerve stimulation device specifically authorized for use prior to the onset of pain.
Cefaly is a small, portable, battery-powered, prescription device that resembles a plastic headband worn across the forehead and atop the ears. The user positions the device in the center of the forehead, just above the eyes, using a self-adhesive electrode, Foreman said.
The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches.
The user may feel a tingling or massaging sensation where the electrode is applied.
The 67-person study showed that those who used Cefaly experienced significantly fewer days with migraines per month and used less migraine attack medication than those who used a placebo device. The device did not completely prevent migraines and did not reduce the intensity of migraines that did occur.
The device is designed for adults and should only be used once per day for 20 minutes, Foreman said.
"Cefaly provides an alternative to medication for migraine prevention," Foreman said in a statement. "This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."
Migraine headaches are characterized by intense pulsing or throbbing pain in one area of the head, accompanied by nausea or vomiting and sensitivity to light and sound.
A migraine can last from four to 72 hours when left untreated. These debilitating headaches affect approximately 10 percent of people worldwide and are three times more common in women than men.
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