The U.S. Food and Drug Administration announced on Tuesday that it has approved the sale of an electronic headband that can treat migraine headaches.
The device is called Cefaly, and is made by Cefaly Technology in Belgium, according to CNET.
The FDA stated that Cefaly is the first transcutaneous electrical nerve stimulation (TENS) device that is specifically approved for use before pain starts, Xinhua reported.
"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."
Cafely is placed over the ears and across the forehead, right above the eyes, CNET reported. An electric current is sent to the skin and the tissue beneath it by a self-adhesive electrode. Cefaly said the current is supposed to stimulate a nerve that has been associated with migraines.
The FDA said it approved the device because of research done in a clinical trial in Belgium, which included 67 people who experienced over two migraine headaches a month and had not taken any medications for the headaches in three months before using Cefaly. The agency said that participants who used Cefaly went through "significantly fewer days" with migraines each month and used less medication than those who used a placebo, according to Xinhua.
Cefaly Technology conducted another study with 2,300 users in Belgium and in France, which found that 53 percent of participants said they were satisfied enough to buy the device. The study also found that so far, no serious side effects are associated while using the headband, CNET reported.
"This device is a promising step forward in treating migraine headaches, as it addresses an important part of what we believe triggers and maintains a migraine attack," said Dr. Myrna Cardiel, a clinical associate professor of neurology at NYU Langone Medical Center and NYU School of Medicine. Cardiel also said the 53 percent positive rating is on the same level as "most oral migraine preventative medications."
