External Nerve Stimulation Device for Migraine Prevention Receives FDA Approval

The Cefaly, an external nerve stimulator that’s worn like a headband across the forehead, has received FDA approval to be marketed in the U.S. for migraine prevention.1 It is available by prescription only.

Availability & Pricing
You can order a Cefaly online (be sure to go to Cefaly.us as Cefaly.com does not currently ship to the U.S.). You must send in a prescription from you doctor before the device will be sent to you. The device itself costs $295 plus $29 for shipping, a set of three electrodes is $25. PayPal is the only payment form currently accepted; you cannot pay directly with a credit card. The company offers a 60-day money-back guarantee if you are dissatisfied with the device.

What, exactly, is the Cefaly?
The Cefaly is a small, battery operated device that stimulates branches of the trigeminal nerve by delivering an electric current to the skin and tissue of your forehead. If you’re familiar with TENS units, you have a pretty good idea of what the Cefaly is. The difference is specially shaped electrodes and preset programming. It also looks like it’s straight out of Star Trek.

How does it work?
How the device works it not well understood, although it is guided by the same principles as any nerve stimulation treatment for migraine. The trigeminal nerve plays a significant role in migraine pain. Stimulating it is thought to change migraine- or pain-related brain activity in a way that increases the migraine threshold.2

How do you use it?
The Cefaly slots into place on a self-adhesive electrode that you apply above your eyebrows. Then you press the button and let it run for 20 minutes. According to the FDA, it is to be used for no more than 20 minutes a day.

1014277_626069444079074_1271734263_n

What does it feel like?
The official press release describes the sensation as a tingling or massaging sensation. That sounds pleasant, but I’ve talked with a half dozen migraineurs who have found the sensation to be so painful that they couldn’t use the device. They all had chronic migraine, so they could have a greater degree of allodynia than the average user. I used the Cefaly daily for six months and mostly found the sensation to be tolerably uncomfortable, but five or six times it was so painful that I actually yelped and had to turn it off.

What are the side effects?
One study reported no side effects. In the other, the most common reported side effects were an intolerance to the sensation in the forehead, sleepiness while the device is on and headache after the treatment session is over. Fewer than 5% of study participants reported any side effects.

What’s the research?
The FDA based its approval on two different studies, one was a small clinical study and the other was a patient satisfaction study of people who rented the device online.

The clinical study included 67 participants who had more than two migraine attacks each month. Some of the participants received a working device, others used a placebo device. They were all instructed to use the device for 20 minutes a day for three months. The participants who used the working device reported fewer migraine attacks each month, fewer headache days each month, and the need to take fewer migraine abortives than those who received the placebo device. No side effects were reported.3

The patient satisfaction study included 2,313 participants who rented the device for at least a 40-day trial period. After an average testing period of 58 days, 55.4% said they were satisfied with the treatment and were willing to purchase it. The remaining 46.6% were not satisfied and returned the device. 4.3% of all participants reported side effects.4

What’s the bottom line?
The Cefaly is probably worth a try if it’s in your budget. The research is early and only covers a short treatment time, but the findings are promising and potential side effects are low.

More information
Your Cefaly Questions Answered
Cefaly: A Migraineur’s Review

Note: This post was updated to reflect the most accurate availability and pricing information as of April 25, 2014

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The Migraine.com team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.
View References
  1. FDA allows marketing of first medical device to prevent migraine headaches: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm388765.htm
  2. Neurostimulation Effective in Migraine Prevention: www.medscape.com/viewarticle/778875
  3. Migraine prevention with a supraorbital transcutaneous stimulator: http://www.neurology.org/content/early/2013/02/06/WNL.0b013e3182825055.abstract
  4. Safety and patients' satisfaction of transcutaneous Supraorbital NeuroStimulation (tSNS) with the Cefaly(R) device in headache treatment: a survey of 2,313 headache sufferers in the general population: http://www.thejournalofheadacheandpain.com/content/14/1/95

Comments

View Comments (18)
  • Staceymae
    4 years ago

    I ordered the Cedar device as soon as it became available. I used it 20 minutes a day, the best I could for at least 2 months. It may have decreased frequency, but it’s hard to say. I also began molecular hydration and physical therapy at about the same time. I am a chronic migrainer, and I found my tolerance to it very low. I could only take it at very low levels. The electrode pads wore out VERY quickly. I went through six in 2 monthes. I am ordering more and giving it a new chance. I had to ask those around me not to make negative comments and be supportive of my Tx. I am hopeful.

  • R.D.Hayes
    3 years ago

    Ma’am, I know that this was a couple of years ago, but could you update us on your results please.

  • KB
    4 years ago

    So I’m not the only one who found it painful! I thought that knowing my luck, I must be one of those tiny percentage who experienced something other than lovely warm “unexpected” and “unusual” sensations…but maybe it’s just that out-and-out PAIN simply isn’t mentioned in the booklet.
    I have had the device for less than a week and have used it at least daily, often for more than one session consecutively. I have transformed migraine and am trying to not go down a path of needing stronger and stronger painkillers; I also suspect I am on the verge of triptan (my godsend) overuse.
    I too found it only just tolerable and it’s still uncomfortable at the most intense phase, but I *think* a) it’s getting more tolerable and b) it just might be helping.
    I now find that if I do more than one session end-on-end, at some point I simply pass out and wake up when it beeps.
    As my partner said – “Honey it’s just electricity and your head. What could possibly go wrong?” Heh.
    So in the past week, I had the first two days of what is normally a four-day session of daily on-waking, gets-worse headache; took drugs those first two days out of habit and fear but then also used the Cefaly a lot, and though I feel a bit spacey, I have woken up these last two days to find the headache is either not there or only the occasional mild twinge that does not need drugs, just a glass of water.
    After a lifetime of migraine (I am 47), it would be simply incredible if this worked.
    Best wishes, everyone.

  • Lifetime_Migraine_Sufferer
    4 years ago

    I’ve had my CEPHALY for months now (I also bought mine from Canada before it was approved in the US). I am a chronic/daily migraine sufferer and I gave the CEPHALY more than a fair shot. I used it as directed; level 2 for prevention – daily, level 3 for acute attacks, and level 1 if I’m feeling particularly sensitive/or unable to tolerate the two higher levels. At first it seemed like a novelty because I never used anything like it before. But I have to say I was disappointed overall. It only comes with a few adhesive strips for the sensor, and they wear out very quickly. There’s nothing else available that can be used as an alternative to their sensors so they have to be used sparingly and properly stored. Therefore I bought some tacky conductive gel on Amazon that helped get more life out of them – particularly since the CEPHALY and it’s accessories were back-ordered for over 6 weeks! In addition, I bought two CEPHALY devices because I was so excited about their study outcomes and I didn’t want to be without one (plus I’m desperate for relief)! Both of the devices had a quality issue with the battery compartment on one side; flapping open as it didn’t have a secure closure. It’s a lot to spend on a device that may/may not help you. The directions stated that the device could be used all day during an acute attack; again, no relief for me. The CEPHALY literature originally stated that the CEPHALY was for those migraineurs that had tried everything without success. It’s a great idea but I think if you have mild or infrequent migraines, it may be more for you.

  • Lifetime_Migraine_Sufferer
    4 years ago

    One more thing… I NEVER got 60 uses out of their sensors, and I treated them like gold – followed every direction. The booklet included even described approximately 15 uses per sensor, so maybe they mean 60 uses with all three sensors??? I don’t know but again what doesn’t work for some may work great for others. Good luck!!

  • Hennie Duits
    5 years ago

    By the way, seeing what the FDA has approved in het past, and how much sad results this has had, do you feel there is good reason to trust what the FDA says?

  • Hennie Duits
    5 years ago

    It would be interesting to know what percentage of the 55.4% satisfied users still will be satisfied after, say, about one or two years. I wouldn’t be surprised if this percentage would drop to, well, maybe 10 or 20% max. The main reason for that would be that the device, just like most pain killers, botox, and you name it, does not get to the root of migraine. It tries to manage the pain, but the root of migraine is in the person suffering from it. If a treatment leaves this root untouched, it will grow back, just like any pest will. Harsh words, but it’s sort of foolish to expect something superficial to yield lasting results – that just doesn’t happen.

  • R.D.Hayes
    3 years ago

    I live with Chronic Daily Migraines…with a sledge hammer in my head from the moment I wake up. I would do anything for some pain relief. If it took my pain for two days, I would call that something that worked. I have lived with these since I was four, with them growing much worse after I had my fourth and final child who is now eight. I have been in so much pain that I have asked my husband to kill me to make it end. I’m not a suicidal person, and only a person who has migraines like mine would understand that statement. I’m not saying that we should jump at every chance when there is no proof that it will work, but I am the type of person that will chew off my left arm if I thought it would give me some relief.

  • Sonya
    5 years ago

    Harsh words indeed. It seems to me that you are saying that the migraine is to be blamed on the one who suffers with it?

  • simplygourdjus
    5 years ago

    To me, it seems like it would act like a “shock” collar but in a Headband form. Or like the “as seen on tv” http://www.alibaba.com/showroom/abdominizer-belt.html…it was advertised to increase ur ab muscles without exercising. ???????????

  • pligthart
    5 years ago

    Hi Kerry, the migraine frequency decreased indeed after I stopped. I think it is as with many treatments, what works for one doesn’t necessarily works for another. It is always trial and error. I truly hope that for some people the device will work very good and I am sure it will. I like the information on migraine.com, this is very useful and interesting and you get a good picture on the different types of migraine, the different kind of treatments and peoples experience. Thanks for writing your great posts.

  • Kerrie Smyres moderator author
    5 years ago

    I’m glad to hear the problems didn’t persist. Thanks for your kind words — we have a great team here at migraine.com. Best wishes in finding some relief.

  • pligthart
    5 years ago

    I have used this device for about 6 weeks in the April/May timeframe in 2013. I have episodic migraines, about 9 to 10 headache days per month. I purchased the device in Canada since it was not yet approved in the USA. The frequency of the migraines got worse and I eventually had to stop using the device. It would be great if there was more information available for which types of migraines this device could work, chronic, episodic with aura, or without aura etc.

  • Kerrie Smyres moderator author
    5 years ago

    Thanks for sharing your experience, Petra. I’m sorry to hear it was so negative. Did your migraine frequency decrease again after you stopped using the device?

    Marketing materials I received yesterday say that it is intended for people who have two to eight migraine attacks per month, but that’s the first time I’ve seen a target market addressed. Study that included only participants who were verified to have migraine says that they had two or more migraine attacks per month. The larger study didn’t clarify the number of attacks and could not definitively say all the participants even had migraine rather than another headache disorder. Both studies included participants who had migraine with aura and those without, although all the participants in the smaller clinical trial who had migraine with aura also had migraine attacks without aura.

  • Nancy Harris Bonk moderator
    5 years ago

    Hi Kerrie,

    Thank you for providing this study to us in a accurate and succinct manner.

    Nancy

  • Kerrie Smyres moderator author
    5 years ago

    Thanks, Nancy. I’m working on a VERY wordy review of my experience with it!

  • Linda
    5 years ago

    We contacted the maker of the Cefaly in Belgium. He wrote back telling us that the cost of the device in the US will be $295.00, $29 for shipping and there will be a 60 day money back guarantee. A kit of 3 electrodes cost $25 dollars and they will last approx. 60 sessions. But it will require a prescription. They can be ordered at http://www.cefaly.us. Once you order it you will have to send a copy of your prescription to the company at info@cefaly.com. However, we went to the site, and did not see a purchase tab yet. They are also available at COSTCO in Canada for $225.00. If you can figure out how to become a member of COSTCO Canada, you can order it straight off line. Hope this post answers questions people have.

  • Kerrie Smyres moderator author
    5 years ago

    Thanks for the information, Linda. It looks like it the shopping cart on Cefaly.us is now functioning.

    I purchased mine from Costco Canada in June 2013, but they would not ship it to the US. I had it sent to a friend who shipped it to me.

  • Poll