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Cefaly migraine prevention headband gets FDA approval

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March 19, 2014

The Cefaly headband is claimed to not only treat migraines, but help to reduce their frequ...

The Cefaly headband is claimed to not only treat migraines, but help to reduce their frequency through regular use

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Though using electrical stimulation of the brain as a means of treating migraines has provided an alternative to over-the-counter medication, the administering of the electrical currents can be complex, involving bulky equipment or even surgically implanted electrodes. Cefaly, a battery-operated headband, has now been approved by the FDA (US Food and Drug Administration) and is claimed to not only treat migraines, but possibly prevent them altogether.

Cefaly is placed on the forehead with the help of a self-adhesive electrode which, powered by two AA batteries, delivers transcutaneous electrical nerve stimulation (TENS) to the trigeminal nerve to either ease the pain during an attack, or in the longer term, help minimize their frequency.

For treatment during a migraine, Cefaly uses high-frequency nuerostimulation, which limits the pain signals from the nerve center. For preventative use, intended for regular sufferers, Cefaly uses low-frequency stimulation to change the migraine's trigger threshold, making it harder to reach and the headaches less painful, or causing them to disappear entirely.

According to the company, users can expect to feel a light sensation when wearing the headband, though it says the dose of electromagnetic waves is weaker than you receive when watching television.

For preventative use, Cefaly is intended to be worn for 20-minute sessions. Pressing a button will begin the session, with the intensity and tingling gradually increasing as time progresses. The idea is to build up a tolerance to the sensation and, in effect, the migraine threshold in your brain, though if the sensations do become too much, pressing the button again will reduce the intensity.

Researchers have been studying the efficacy of Cefaly since 2011 through a series of clinical studies, the most recent of which applied the treatment to 2,313 headache sufferers across an average of 58.2 days each.

Some 54.4 percent of the subjects tested reported satisfaction with the treatment provided by Cefaly and were willing to purchase the product, while only 4.3 percent reported adverse effects, all of which were minor and fully reversible.

Cefaly is priced at US$295, while the kit of three electrodes, which should be good for 15 to 30 uses, will cost an additional $25.

An informational video describing the Cefaly can be viewed below.

Source: Cefaly

About the Author
Nick Lavars Nick was born outside of Melbourne, Australia, with a general curiosity that has drawn him to some distant (and very cold) places. Somewhere between enduring a winter in the Canadian Rockies and trekking through Chilean Patagonia, he graduated from university and pursued a career in journalism. He now writes for Gizmag, excited by tech and all forms of innovation, Melbourne's bizarre weather and curried egg sandwiches.   All articles by Nick Lavars
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4 Comments

So why would the FDA have any interest in non food and drug type products?

Nairda
20th March, 2014 @ 07:18 am PDT

@naidra - Class II Special Controls.

Craig Brockman
20th March, 2014 @ 09:19 am PDT

I was missing a link to FDA: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm388765.htm

Ernesto Simón
23rd March, 2014 @ 09:53 am PDT

This looks a bit suspect to me. Did they do a blind trial to test for the placebo effect?

I'm surprised that no-one has brought out a magnetic headband, or maybe a copper band (both probably non-functional), but could be sold to gullible people.

Would there be a refund if it doesn't work? Probably not.

windykites1
3rd April, 2014 @ 03:49 am PDT
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