The U.S Food and Drug Administration (FDA) on Tuesday approved the first medical device for preventing migraine headaches. The device, called Cefaly, works by stimulating nerves beneath the forehead that trigger migraine headaches.
Made by a Belgian company, Cephaly Technology, Cefaly is a small, portable and battery powered nerve-stimulating device that looks like a plastic headband.
Just like a tiara, this prescription device is worn across the forehead and atop the ears. Cefaly is positioned in the center of the forehead with a self-adhesive electrode. This small electrode applies an electric current to stimulate the migraine-inducing trigeminal nerve.
The device uses the transcutaneous electrical nerve stimulation (TENS) technology to emit an electric impulse that is transmitted to the skin and underlying body tissues to stimulate branches of the trigeminal nerve. The technology triggers the pain center of the brain evoking it to produce more endorphins to relieve the migraine.
“Cefaly provides an alternative to medication for migraine prevention,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.”
The FDA’s approval for the device is based on a study of 67 people in Belgium and a patient satisfaction study of 2,313 Cefaly users in France and Belgium.
The 67-person study showed that those who previously suffered more than two migraine attacks a month reported significantly fewer days with migraines per month after using Cefaly compared to those who used a placebo. These patients also reported a reduced need for migraine medication compared to placebo group.
In the 2,313- migraine patients study, about 53 percent of the patients said they were satisfied with the Cefaly headband and wanted to purchase it for future use.
However no serious adverse events took place during either study, some participants reported sleepiness while wearing the device and migraine pain and headaches after the treatment session.
The FDA, an American health watchdog within the U.S. Department of Health and Human Services, has indicated Cefaly for patients aged 18 years and older and to be used not more than for 20 minutes once a day.