-- Scott Roberts
WEDNESDAY, March 12, 2014 (HealthDay News) -- 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
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
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
The device is produced by the Belgian firm STX-Med.
The FDA has more about
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