For the first time, the US Food and Drug Administration (FDA) has approved the marketing of a device for the preventative treatment of migraines.
Called Cefaly, the small battery-powered device looks like a plastic headband that is worn across the forehead and atop the ears. Using a self-adhesive electrode, the user positions the device in the center of the forehead. According to the FDA, Cefaly then delivers "an electric current to the skin and underlying body tissues in order to stimulate branches of the trigeminal nerve."
The device is indicated for adult patients (over the age of 18) and should only be used once per day for 20 minutes, according to the FDA. In a press statement, Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said: “Cefaly provides an alternative to medication for migraine prevention. This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.”
The marketing approval was based on safety and effectiveness data from a clinical study conducted in Belgium. The trial included 67 individuals who experienced more than two migraine headache attacks a month and who had not taken any medications to prevent migraines for three months prior to using the device. The results showed those individuals who used Cefaly reported significantly fewer migraine days per month and used less migraine attack medication than those who used a placebo device. However, the device did not completely prevent migraines and did not alter the intensity of migraines that did occur.
The FDA also reviewed a patient satisfaction study of more than 2,000 Cefaly users in France and Belgium, and found that a little more than 53 percent of patients were “satisfied with the treatment and willing to buy the device for continued use.” Common complaints included “dislike of the feeling and not wanting to continue using the device, sleepiness during the treatment session, and headache after the treatment session.”
There were no serious adverse events during either study. The device was approved through the de novo premarket review pathway, which is intended for generally low- to moderate-risk medical devices that are not substantially equivalent to a device which is already approved and on the market.
Cefaly is manufactured by STX-Med in Herstal, Liege, Belgium.
See Neurology Now’s previous coverage of migraine therapies that target the trigeminal nerve: http://bit.ly/10LqdSE.