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Last Tuesday, the US Food and Drug Administration (FDA) approved the first device to prevent migraines.
Called Cefaly, this device “provides an alternative to medicine for migraine prevention,” Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in a statement. “This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.”
The Cefaly device is a battery-powered, plastic gadget worn around the forehead, like a visor. It features a self-adhesive electrode that delivers small electrical impulses to stimulate the trigeminal nerve, which is involved in head pain.
Approval for the device was based on a clinical study involving 67 people from Belgium who had more than two migraine headache attacks per month and who had not taken any medication to prevent the attacks for three months prior to the study. Compared to those who used a placebo, the people who tested the headband reported fewer migraine attacks per month and used less medication to relieve their headaches. However, the device did not completely eliminate the migraines, nor did it reduce their intensity.
The new migraine relief device was also tested by an additional 2,313 people in France and Belgium. A little more than half of the users (53 percent) said they were satisfied with the Cefaly treatment and that they’d buy one for themselves. Other users complained about wearing the device, or that they felt sleepy or suffered headaches after treatment.
Cefaly is designed for users 18 years of age and older, and should not be used for more than 20 minutes a day, according to the FDA. Cefaly is currently available in Canada Costco stores and on Amazon.com.
For those who experience frequent migraine headaches and tension headaches, here are a few tips that may help:
Photo Credit: Cefaly
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