FDA Approves First Medical Device For Preventative Treatment of Migraine Headaches

Have you heard of Cefaly? Would you try it?

Ohio Migraine Awareness


By Migraine.com—April 21, 2014

In March of 2014, the FDA announced that they would allow marketing of the first transcutaneous electrical nerve stimulation (TENS) device for the preventative treatment of migraine headaches.

Cefaly is a small, portable, battery-powered device similar to a headband and is worn across the forehead, resting on top of the patient’s ears.1 The device is positioned in the center of the patient’s forehead using a self-adhesive electrode. The bipolar electrode bilaterally covers the origins of the supraorbital nerves (branches of the 1st trigeminal division) while a constant current generator produces biphasic rectangular impulses. These impulses cause a tingling or massaging sensation; the patient has the ability to control the intensity should it be too much when treatment is first started.Cefaly should be used once daily for 20 minutes, during which time the patient can relax or continue with daily activities.

While this device is new, the use of TENS…

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