Over ten percent of the U.S. population suffers from migraines, and currently-approved treatments are not always effective and can produce adverse effects. Now, migraine sufferers may be able to get some relief from a newly FDA-approved device. The device is made by a Belgian company, Cephaly Technology, and they call it Cefaly. It is the first transcutaneous electrical nerve stimulation (TENS) system approved for pain prevention, as well as the first FDA-approved method for migraine prevention.
The device consists of a battery-powered headband that delivers an electric current to the nerves and is meant to be used by adult patients once a day for twenty minutes. It has previously been approved in Europe and Canada, where 54 percent of patients have reported experiencing fewer migraines after using the device.
The FDA approved this device based on the PREMICE (Prevention of Migraine using the STS Cefaly) trial, which included 67 adults randomized into two groups: one group used the Cefaly device and the other served as a control group. The patients who actually wore the device reported two fewer headache days per month, while the control group reported no change. And 38 percent of those patients using the device reported a 50 percent reduction in monthly headache days. No serious adverse effects were reported.
ACSH s Elizabeth Whelan comments: Migraines can be extremely debilitating. Oftimes, once a migraine sets in, many of the approved medications for migraines will no longer be effective. This FDA-approved prevention device has the potential to help those who regularly suffer from migraines and hopefully lead to fewer migraines experienced. Certainly the lack of side-effects is a big plus.