FDA Gives Green Signal to Electrical Headband for Migraine Prevention
Sometimes even painkillers and medications are not enough to ward off painful migraine headaches. Keeping that in mind, the Food and Drug Administration has given green signal to a medical device that will prevent migraines.
The device called Cefaly is an electrical headband produced by Cephaly Technology of Liege, Belgium. The device is considered as a Transcutaneous Electrical Nerve Stimulation or TENS device. It is worn in forehead and rests on the ears.
It releases low electrical energy that acts as a 'counterirritant' to the nerves, preventing further pain, said Neurology Professor Peggy Mason from University of Chicago. To get the device, a prescription will be needed.
The device will give a message sensation for a session of 20 minutes. The device has already been approved in Canada and it can be brought for around $300 USD. As per Michael Solomita, Vice President of Roxon Medi-Tech Ltd of Canada, it may be available in the US on the same rate.
Director of the FDA's Medical Device Center Office of Device Evaluation said the medical device will prove quite beneficial for patients who are unable to tolerate current migraine medications for preventing migraines.
"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 treatment", said Dr. Eishi Asano from Wayne State University in Detroit.
A clinical trial was carried out to prove the efficacy of the device. Experiment was carried out on 67 patients and it was found that 38% of users had witnessed a decline of at least 50% in their migraine episodes.
Before the treatment, participants witnessed 6.94 days of migraine headaches in a month and the number was lowered to 4.88 days after the treatment. The study was published in the journal Neurology.
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