It was only last year that the results from a study of the impact of nerve stimulation on migraine sufferers were published in the journal Neurology. But now, the general public will be able to use this stimulation, thanks to the news announced from the FDA this past Tuesday: A headband delivering electrical nerve stimulation can prevent onset of migraine headaches and can be marketed for that purpose in the United States.
The product is currently named “Cefaly,” and the Belgian-made device is the first to win FDA approval for migraine prevention, and in fact is also the first transcutaneous electrical nerve stimulation (TENS) system approved for any type of pain prevention. (Recall that TENS units are often used in the acute setting to treat pain.) Results of the aforementioned study were impressive enough to warrant approval: The study involved 67 migraine patients. All participants were outfitted with a wearable device called a "supraorbital transcutaneous stimulator," or STS, which was placed on the forehead and designed to deliver electrical stimulation to the patient's supraorbital nerve.
Subjects in the study routinely had been experiencing a minimum of two—and an average of four—migraine attacks per month. And while some enrolled in the study had previously tried standard drug-based treatments, none had been taking any type of preventive chronic anti-migraine treatment in the three months leading up to the study launch: they were “washed out,” so to speak. This was a placebo-controlled study: of the two groups studied, one group's electrode was a sham device that exerted an ineffectively weak electrical pulse, while the second group wore a working STS.
Participants kept migraine diaries, and the reading of these diaries revealed that migraine severity did not decrease much. However, by the third month of the study, those using the working devices saw the frequency of their attacks drop from about seven per month to fewer than five.
So-called sham device users (the “Control”) experienced no such drop-off.
In addition, 38 percent of the working device users saw their attacks drop off by at least half, compared with 12 percent for those using fake stimulators. Monthly use of anti-migraine drugs to cope with migraine attacks when they occurred dropped by nearly 37 percent among STS users, with no drop among the sham group.
It is not clear how this device works; but it appears there were no serious adverse events.