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A new headband device called Cefaly has been approved by the FDA for the prevention and treatment of migraines. It works by generating an electric current to the skin through the tissue.
This stimulates branches of the trigeminal nerve, which has been associated with migraine headaches. The device is battery operated.
Cefaly is placed on the center of the forehead above the eyes and over the ears while electrodes in the headband transmit the impulses to the nerve. The device is only to be worn for 20 minutes per a day. "The user may feel a tingling or massaging sensation where the electrode is applied," reports the FDA.
Migraines affect millions of Americans, according to WebMD. A migraine often involves throbbing intense pain on one side of the head. The person may have nausea, vomiting and increased sensitivity to light and sound. Women are affected three times more often than men.
The Cefaly headband works on the same principle as TENS (transcutaneous electrical nerve stimulation). The electrodes in the headband transmit low voltage electrical pulses into the tissue and nerves underneath.
The sensation created is mildly pleasant and acts to counter-stimulate the nerves. The exact mechanism is not entirely understood but it is thought that changes in the signaling of the nerves may release certain neurotransmitters.
Dr. James Rathmell, chief of the pain medicine division at Massachusetts General Hospital in Boston told NPR.com, TENS is about "putting a pleasant sensation over an area where there is a painful sensation."
The Cefaly headband was cleared by the FDA on March 11, 2014 after a clinical trial of 67 people showed that people who wore the headband for 20 minutes a day took less migraine medication than the control group who wore a sham headband.
A previous satisfaction survey of over 2,000 people was given to wearers of Celfaly in France and Belgium who had rented the devices for 40 days. Unfortunately, almost half of the wearers did not use the device for the recommended time so they did not feel they wanted to continue using it.
However, the other “54.4% of subjects were satisfied with the tSNS (Cefaly) treatment and were willing to purchase the device.” Less than 5 percent of those users had any adverse experiences using it. The most frequent complaints were discomfort with the headband, difficulty sleeping and fatigue.
NPR reported that the headband, which is made by STX-Med, costs $295. A package of three electrodes (good for about 60 treatments) will run $25.
The battery-powered headband will be available to be purchased online, but a copy of a doctor's prescription will need to be emailed to the company.
Sources:
Electronic Headband Prevents Migraines With Tiny Jolts by SCOTT HENSLEY. NPR.org. Web. Mar. 23, 2014.
http://www.npr.org/blogs/health/2014/03/13/289787263/electronic-headband...
Schoenen J. et al. Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial. Neurology. 2013 Feb 19;80(8):697-704. doi: 10.1212/WNL.0b013e3182825055. Epub 2013 Feb 6.
http://www.ncbi.nlm.nih.gov/pubmed/23390177
FDA Approves First Device to Prevent Migraines. Wearable headband uses electrodes to stimulate nerve tied to the headaches. WebMD. Web. Mar. 23, 2014.
http://www.webmd.com/migraines-headaches/news/20140311/fda-approves-firs...
Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues. Other articles by Michele are at www.helium.com/users/487540/show_articles
Edited by Jody Smith
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