FDA approves medical device to treat migraine headaches

migraine headband FDA approves medical device to treat migraine headachesThe Food and Drug Administration (FDA) has approved a novel new nerve-stimulating headband designed to treat and prevent migraine headaches. The device offers a new option for migraine sufferers who cannot tolerate migraine medications.

The Cefaly device is a battery-powered plastic headband that is worn across the forehead. The band emits a low electrical current through an adhesive electrode to help stimulate nerves that trigger migraines. The headband is designed to be worn for up to 20 minutes a day in adult patients age 18 and older.

The device was approved based on a 67-person study that showed those using the device had fewer migraines during a month’s period than patients using a placebo device. A separate trial showed that slightly more than half of the 2,313 study participants were satisfied with the device and would be willing to purchase it in the future.

Some users say they feel a tingling sensation on the skin where the electrode is applied. They also said that the headband did not completely eliminate headaches or reduce the intensity of migraines that occurred. No serious adverse reactions were noted.

Late last year, the FDA approved another device to treat migraines. The Cerena Transcranial Magnetic Stimulator, or Cerena TMS, is a magnetic device designed to be used after the onset of headaches that are proceeded by auras. Users hold the device with both hands against the back of the head and press a button to release a pulse of magnetic energy to stimulate the occipital cortex in the brain.

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