If you're among the roughly 10 percent of people who suffer from migraines, there's a new device on the market that could help prevent those debilitating headaches in the first place.
Made by Cefaly Technology in Belgium, the device, simply called Cefaly, is an electronic headband that sits over the ears and across the forehead, just above the eyes. A self-adhesive electrode sends an electric current to the skin and the tissue just beneath it to stimulate a nerve (the trigeminal) that Cefaly says has been associated with migraines.
Though the Food and Drug Administration just approved the device today, to be used by prescription only and for no more than 20 minutes a day, it's already available in other countries -- including Canada, where it costs $300.
The FDA says it approved Cefaly because of a clinical trial in Belgium showing that, of the 67 participants who suffered through migraines at least twice a month and hadn't taken meds for the headaches in the three months leading up to the study, those who used Cefaly spent "significantly fewer" days dealing with migraines than those using a placebo device.
Cefaly Technology also points to a study it conducted involving 2,300 users in Belgium and France, in which it found that 53 percent of participants reported being satisfied enough to buy one. And while a coin toss may not seem terribly impressive, and some users complained of sleepiness during the treatments and headaches after, it's no small feat that more than half the participants liked it enough to want to buy it.
Perhaps the best finding is that no serious side effects have yet to be associated with the headband.
"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," Dr. Myrna Cardiel, a clinical associate professor of neurology at NYU Langone Medical Center and NYU School of Medicine, told HealthDay. She added that the 53 percent positive rating is on par with "most oral migraine preventive medications."
Cefaly Technology should be coming out with more purchasing details soon. Meanwhile, check out the device in action in the promo video below: