First Device Approved to Prevent Migraines
WEDNESDAY, March 12, 2014 -- The first device designed to prevent migraine headaches among adults has been approved by the U.S. Food and Drug Administration.
Cefaly is a battery-powered, headband-like device that's worn across the forehead. It provides mild electrical stimulation to the trigeminal nerve, which has been associated with migraines, the agency said in a news release. The user may feel a tingling or massaging sensation where the applied electrode touches the skin.
This is the first transcutaneous electrical nerve stimulation (TENS) device approved to prevent pain, the FDA said.
Migraines are characterized by intense throbbing on one side of the head, sometimes accompanied by nausea and sensitivity to light and sound. Untreated, the pain lasts four hours to 72 hours. Migraines are three times more common in women than men, the FDA said.
The device is meant to be used only once daily for 20 minutes. It was evaluated in a Belgian study of 67 people who were prone to getting more than two migraines per month. The device, while shown to be effective among some users, did not completely prevent migraines or reduce their intensity, the FDA said.
The most common adverse reactions were not wanting to continue to use the device because of the electrical stimulation feelings, sleepiness and headache, the agency said. No serious side effects were reported.
The device is produced by the Belgian firm STX-Med.
The FDA has more about this approval.
Posted: March 2014