Device to prevent migraines gets FDA approval
The U.S. Food and Drug Administration (FDA) has, for the first time, approved a device for preventing migraines--a headband that delivers a nerve-stimulating low electrical current. Its inventors believe it could be helpful for migraine sufferers who can’t take drugs.
The device, called Cefaly, stimulates the trigeminal nerve, which has been associated with migraine headaches. It’s manufactured by STX-Med in Herstal, Liege, Belgium, and is available only by prescription for patients 18 and over. It's designed to be used once a day for 20 minutes.
The FDA looked at a study conducted in Belgium to determine the efficacy of the device. The research involved 67 people who were having at least two migraines a month and who had stopped taking migraine medication for three months prior to the trial.
Results showed that compared with patients who used a dummy device, those using Cefaly had significantly fewer days per month with migraines and used less medication. The device, however, did not eliminate migraines nor reduce their intensity.