After a trial showed that a device worn like a tiara for 20 minutes reduced the incidence of migraines by as much as 50 percent in some people, the Food and Drug Administration has approved it for use in the United States.
Called Cefaly, the device stimulates nerves beneath the forehead — apparently without side effects beyond a tingling sensation during use.
“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,” Dr. Eishi Asano, associate professor of pediatrics and neurology at Wayne State University in Detroit, told CNN.
Researchers reported in the journal Neurology that 38 percent of 67 subjects in a trial had half as many migraine episodes while using the device. The attacks they did have were just as severe, however. Because of the lack of known side effects, researchers think the headband could be combined with other drugs.
The headband is already available for $250 in Canada.