14 DAY TRIAL // Officials with the US Food and Drug Administration (FDA) announced on Tuesday, March 11, that they have allowed the marketing of a headband-like device called Cefaly as the first medical equipment capable of preventing migraine headaches. The instrument is worn across the forehead and over the ears and is touted as an effective way to prevent migraines from setting in at all.
In a statement accompanying its decision, the FDA reveals that Cefaly is attached to the forehead via a self-adhesive electrode, just above the eyes. The device works by releasing a small amount of electrical current through the scalp and skin and into the superficial branches of the trigeminal nerve.
Previous studies have associated this nerve to the development of migraine headaches, and scientists have since determined that applying small amounts of current to its branches can lead to significant improvements. Cefaly is the first piece of medical equipment to take advantage of this data.
At this point, the device is only available through prescriptions, the FDA reports. It is manufactured by a company called Cefaly Technology, which is based in Belgium. The instrument can be worn for up to 20 minutes per day and is not recommended for use on children. According to the new statement, the device may trigger tingling or massaging sensations at the location where it attaches to the head.
“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,” explains Christy Foreman, who is the director of the Office of Device Evaluation at the FDA Center for Devices and Radiological Health.
Untreated migraines can last anywhere from 1 to 72 hours and produce a host of negative side-effects, ranging from pulsing or throbbing pain in various areas of the head, nausea, and vomiting to sensitivity to both light and sound. Around 10 percent of the world's population suffers from this condition, according the latest statistics from the National Institute of Health (NIH).
The FDA team based its decision to allow for the marketing of Cefaly as a way to prevent migraines on the results of a clinical trial conducted on 67 patients in Belgium, all of whom suffered from at least two migraine episodes per month. None of the test subjects ever received medication for their headaches. Another 2,313 Cefaly users from France and Belgium were also surveyed.
On average, people who used the device reported fewer migraine episodes per month and reported using fewer migraine pills overall. This correlation held even when researchers repeated the experiment using a control group of patients who received a placebo therapy, Science Blog reports.
At the end of the study, around 53 percent of the patients reported an interest in buying and continuing to use Cefaly. Those who did not want to purchase the device complained about falling asleep during use, about the way the instrument felt on their heads, and about headaches after using it. No significant adverse effects were recorded during this trial.