The FDA has decided to allow marketing of a new at-home transcutaneous electrical nerve stimulation (TENS) device–called Cefaly–to be used for migraine headache prevention. The device was said to be useful for people who do not currently tolerate migraine prevention medications.

What Is Cefaly?

Cefaly is a small, portable, battery-powered prescription device that looks like a tiara that might have been worn by a Space Princess in Buck Rogers. It is silver and sleek with organic curves and a roughly diamond-shaped structure that rests in the middle of the forehead. Arms rest over the ears.

The device applies an electric current to the skin that is intended to stimulate the branches of the trigeminal nerve, which has been implicated with a causal role in migraine headaches. Patients who are 18 or older can use the device once a day for 20 minutes to prevent migraines.

Modest Results

The FDA based its decision on two studies of the device, which has been in use in France and Belgium for several years. One study looked at 67 individuals who had more than two migraines a month and had not used migraine prevention medications for three months. In this study, people who used the device experienced fewer migraines and used less pain medication than those who used a placebo device. Cefaly had no impact on the severity of migraines that did occur.

The second study was a customer satisfaction survey of more than 2300 users of the device. The survey showed that 53% of users were satisfied with their results and were willing to buy the device for continued use, while only 4% experienced minor, reversible side effects.

The company website lists higher effectiveness data than the FDA reported.

More Effective Migraine Treatment

Although stimulating the trigeminal nerve can be an effective way to prevent migraines, there is often more to migraine attacks than just trigeminal nerve involvement. TMJ treatment can help not only with trigeminal nerve problems, but also with muscle tension and tension headaches that can also serve as migraine triggers. TMJ treatment has been shown not only to reduce the incidence of migraines, but also their severity.

To learn more about whether TMJ treatment can help with your migraines, please call (303) 691-0267 to schedule an appointment at the TMJ Therapy & Sleep Center of Colorado in Denver.