The FDA has given approval to market the first transcutaneous electrical nerve stimulation (TENS) device for the treatment of migraine headache. The device is also the first to be specifically authorized for use prior to the onset of pain. The device provides an alternative to medication for migraine prevention, and may benefit patients who are intolerant of current migraine medications for prevention or therapy.
The device, Cefaly, is manufactured by STX-Med in Herstal, Liege, Belgium. Cefaly is a small, portable, battery-powered, prescription appliance 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. 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 sensation where the electrode is applied. Cefaly is indicated for patients 18 years of age and older and should only be used once per day for 20 minutes. Read the FDA news release here.