Nerve-Stimulating device approved for sale for migraine sufferers

New device for migraines is no cure but may help some. The studies are lukewarm.

FDA Approves Nerve-Stimulating Headband To Treat Migraines.

The Food and Drug Administration is convinced by Belgian studies that this could be helpful to those who suffer from this common type of headache with throbbing pain, nausea and light and sound sensitivity.

The FDA approved Cefaly, a battery-operated band that goes across the forehead with self-adhesive electrodes. The idea is to electrically stimulate for 20 minutes a day the trigeminal nerve, which senses pain in the face and parts of the head.

The approval is based on a clinical trial of 67 adults who had at least two attacks a month. After going without medication for three months, they got either the actual device or a placebo device.

Those who got the actual device needed less medication and had fewer days with migraine.

Press release from FDA.

The idea for this is not new even though this device is and it looks futuristic. As soon as this story came out, many who are used to seeing quack devices or treatments that promise more than they deliver were dubious. This is only one placebo controlled study with only 67 people. That’s not much. A large survey (2313) of people who rented the device resulted in only about a 50% success rate. It appears to be safe but not always effective for some people. Still, perhaps for those in which it does work, it will provide welcome relief. It’s pricey at $300 and some people find it uncomfortable; probably more comfortable than a migraine though.

More: Electronic Headband Prevents Migraines With Tiny Jolts : Shots – Health News : NPR.


Thanks to multiple people who sent us this story.

  5 comments for “Nerve-Stimulating device approved for sale for migraine sufferers

  1. Lee
    March 17, 2014 at 10:49 AM

    At 300 bucks a pop, the only stimulation this is inducing is to the entity whose bank account the money is going into! A study only involving 67 people is just plain silly. It can also double as a “She Ra, Princess of Power” Tiara!

  2. Mike Skotnicki
    March 17, 2014 at 1:21 PM

    If 50% of people saw improvement in their migraines, that’s a better efficacy rate than many prescription drugs and it’s probably seen as a wondrous device by those it helped. Perhaps others can get all or part of their money back.

    Many medical studies only use relatively small groups of test subjects. The studies are expensive and after you get a certain number of people, statistics show that there is little variation after that. Like exit polling national elections.

    March 17, 2014 at 4:44 PM

    I’ll stick to the triptans. There is a lot of quackery associated with migraine treatment and prophylaxis

  4. Phil
    March 18, 2014 at 4:12 AM

    I won’t dismiss this yet. Stimulating a nerve isn’t the same as pharmaceuticals. It may only work in some people. Having said that, I’m amazed the FDA approved this with such a small sample size.

  5. Carol
    March 20, 2014 at 4:56 PM

    If someone gave me one I’d try it. Migraines are awful, and I would look like a pretty princess wearing it.

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