First Electrical Nerve Stimulation Method to Prevent Migraines Approved

A transcutaneous electrical nerve stimulation (TENS) device that is used to prevent migraines was approved by the FDA. This marks the first time the FDA approved a device to be used for the prevention of migraines and the first time a TENS device was approved. The device, Cefaly®, which is manufactured by STX-Med in Herstal, Liege, Belgium, is meant to prevent migraines for individuals who suffer from the condition and cannot tolerate current migraine medication. The FDA approved the device through a regulatory pathway for low to moderate risk medical devices, which are not substantially equivalent to another product already on the market, and after review of a 67-person clinical study and a patient satisfaction study that polled over 2,000 users.    


Cefaly is designed specifically to be used by migraine sufferers prior to the onset of pain. Typically migraines are characterized by intense pulsing or throbbing on one point on the head. Migraines can often be accompanied by nausea, vomiting, and sensitivity to light and sound and can last from four to 72 hours. According to a study referenced by the FDA, migraines affect 10 percent of the individuals across the world and affect women at a rate three times higher than men.


The approved device is a small, portable, battery operated plastic headband that is made to be worn “across the forehead and atop the ears.” Cefaly delivers an electric current, which to the user may feel like as a gentle massage or tingling sensation, to the skin and underlying tissue after the user positions the device, which includes a self-adhesive electrode, in the center of the forehead, above the eyes. It is reported that Cefaly is meant for use in patients who are 18 years of age or older and is not intended to be utilized for more than 20 minutes per day.

FDA Approval

The FDA approved the device through a de novo premarket review pathway, which is a manner of approval used for low to moderate risk medical devices that are not substantially equivalent to other devices already on the market. The FDA also reviewed the findings of a 67-person clinical study in Belgium and a patient satisfaction survey in France and Belgium. The study investigated the effects on patients who suffer from migraines twice or more a month and who had not taken any medication for the condition for the previous three months. From that analysis, the FDA noted the although the Cefaly users still experienced migraines at points and continued to have migraines of the same and usual intensity, they also experienced less migraines and used less migraine attack medicine than other participants that were given a placebo device. According to the patient satisfaction survey, of the 2,313 users polled, a little over 53 percent stated they would be willing to purchase Cefaly, while others reported complaints of sleepiness during the treatment, headaches after the use, and dislike of the sensation of the delivery of the electric current.