On Tuesday the Food and Drug Administration announced its approval of a device for preventing migraines. Called Cefaly, it’s the first transcutaneous electrical nerve stimulation (TENS) device designed for use prior to the crushing pain of such headaches.
Migraines are defined as throbbing or pulsing pain in one area of the head, and symptoms can include nausea and sensitivity to light and sound. A migraine lasts four to 72 hours if untreated.
“Cefaly provides an alternative to medication for migraine prevention,” Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in a statement. “This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.”
The small, battery-operated, portable device resembles a plastic headband. It’s placed on top of the ears and worn across the forehead, delivering electrical impulses to stimulate the trigeminal nerve. This nerve is believed to contribute to migraine pain. According to the FDA, the device should be worn once daily for about 20 minutes and is intended for those 18 and older.
The FDA approved the device after a small clinical study in Belgium involving 67 people. Participants experienced at least two migraines per month and hadn’t taken drugs to prevent the headaches for three months before the study.
While Cefaly didn’t prevent migraines completely, it did help participants experience fewer “migraine days” per month. Most common issues were tingling sensations and sleepiness during device use, along with subsequent headaches. The FDA reported no serious side effects.
A patient satisfaction survey asking 2,313 Cefaly wearers in France and Belgium to rate the device found about 53 percent satisfied with Cefaly treatment and willing to purchase the device.
Cefaly is currently priced at €295 on www.cefaly.com.