The Food and Drug Administration (FDA) has approved the first medical device in the form of a headband that can prevent migraines.
The battery-powered device, called Cefaly, works by stimulating nerves beneath the forehead. It is positioned just above the patient's eyes, and delivers an electrical current that the wearer feels in the form of a tingling sensation. The gadget, manufactured by the Belgium-based company STX-Med, is to be worn no more than 20 minutes a day.
Cephaly may possibly be combined with other drugs, and unlike typical migraine medications, it has no side effects.
"Cefaly provides an alternative to medication for migraine prevention," Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health, said in a statement. "This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks."
Migraines stem from stimulation of the trigeminal nerve, which may add to the frequency or intensity of a migraine attack.
In a recent study published by the journal Neurology, 67 participants were included in a randomized study to test the headband's effectiveness. From 20 minutes of use per day, the device showed a decrease in migraine episodes to just two a month, and 38 percent of users reported a 50 percent decrease in migraine occurrences. However, it did not lessen the severity of these attacks.
The device, which costs $250, is currently available without a prescription in Europe, South America, the Middle East and Canada.
"New therapies are needed in migraine, and further studies of neurostimulation using innovative study designs are warranted to explore the optimum way to create an acceptable evidence base for widespread use of this potentially valuable treatment," wrote Dr. Eishi Asano, associate professor of pediatrics and neurology at Wayne State University in Detroit, according to CNN.
