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Cefaly Take Two: Revamped Migraine Medical Device Available in U.S.

The business of wearable medical technology is booming. From biofeedback headgear for relaxation to contact lenses that can detect glucose levels, anyone with some extra cash to burn is sure to become a bionic cyborg in no time.

The Cefaly, developed by a Belgium-based company, allows at least some people with migraine to jump on the bandwagon and try their luck with non-pharmaceutical medical technology. According to the information booklet that comes with the Cefaly, the tSNS (transcutaneous Supraorbital NeuroStimulation) device sends electrical signals to the the trigeminal nerve – the nerve that is responsible for pain and sensation in the face – to both block pain signals and stimulate endorphins.

Cefaly Technology has just released a more compact and convenient FDA approved model, Cefaly II, so far available exclusively in the U.S. with a prescription. It will be basically the same as the first Cefaly in function, but the compact design uses magnets making it easier to transport, and the rechargeable USB lithium battery means no more purses full of extra triple As. The only other difference is that users have the option to “ramp up” to full intensity as quickly as they like.

cefaly2_US_buste_02_WEB (1)

“But!” you ask, “Before I blow a whopping $349.00 plus tax, shipping, and roughly $13 per month for the cost of electrodes, does it actually work?”

According to the Journal of Headache and Pain, just over half of their 2,313 test subjects with migraine were satisfied with the Cefaly I, but many of those who were unsatisfied did not use the device as recommended: “After a testing period of 58.2 days on average, 46.6% of the 2,313 renters were not satisfied and returned the device, but the compliance check showed that they used it only for 48.6% of the recommended time. The remaining 54.4% of subjects were satisfied with the tSNS treatment and willing to purchase the device”¹

Cefaly Technology frames clinical findings in a more favorable light, stating in their recent press release that “in clinical trials 81% of compliant patients showed a significant reduction in migraine attacks and up to a 75% reduction in consumption of migraine medications.”

Adverse side effects have only been noted in a small percentage of patients, and mostly relate to discomfort, pain, and the odd allergic reaction to the electrodes, for which an alternative is available.

While these findings are promising, I do wonder what got in the way of regular use of the device for so many subjects. The amount of “non-compliance” cannot be explained by adverse reactions to the device alone, so perhaps people found it difficult to fit into their lives for other reasons. Maybe the new compact design will make regular use more feasible?

Anecdotally, I’m pleased to share my own Cefaly success story. I received my Cefaly (the original Star Trek-like headband/tiara version) in the mail from Costco.ca over a year and a half ago without a prescription. The Canadian version came with two very similar settings. Desperate for relief, I immediately started using it several times a day on the preventative setting, plus additional sessions on the slightly more intense abortive setting during an attack. Although it’s hard to determine the efficacy of any one treatment when there are so many other factors beyond our control (the weather for instance), I did see a 30% decrease in migraine attacks in the following months. Unfortunately, this was not enough improvement to warrant a substantial decrease in my medication use, but it did mean about two to four fewer nights a month of crying into an icepack, so that counts for something.

I have continued to use the device diligently since, and while I can’t say for sure that it has helped preventatively, I can say with certainty that it often helps to decrease my acute head pain during an attack. It can be difficult to concentrate or move around while wearing the device, so I also make a point of sitting quietly or sometimes even meditating while wearing the device, which may be a contributing factor in its efficacy.

My criticisms are these:

  1. The cost. I am lucky that a family member offered to foot the bill for my device, but for many people with migraine whose ability to work has been affected by their health, $349.00 U.S. plus the cost of electrodes is no small sum. I hope that as the device gains popularity the price will come down, but I won’t hold my breath.
  2. The Cefaly beeps. A lot. It beeps when it starts; it beeps when I change the intensity; it beeps several times when it is done; and it gives out one long beeeeeeeep when the battery is running low. This is just mildly annoying when I’m using it preventatively, but when I’ve got a raging migraine, those beeps are like nails driving into my sad sensitive brain.
  3. The blinking light. Since the device sits on the forehead, only others can see the blinking light which indicates the Cefaly is in use. The user cannot see it unless they look in the mirror. Typically the sensations of the active device are very noticeable, so the blinking green light seems like overkill. I do wear my device in public, and I look strange enough with a big hunk of silver plastic on my face as it is. I’d rather not be emitting a small green light as well.

Most of my friends and family have volunteered to try the device. Some found the sensations excruciating, and others barely noticeable. Interestingly, like myself, one friend found it distractingly painful one day, and entirely satisfying the next.

If you do take the plunge, be sure to save your receipt and packaging to take advantage of the 60-day money back guarantee if necessary. Perhaps you can try one at a pain/migraine and headache clinic before buying or even search out a used Cefaly at a reduced price (there must be many out there gathering dust). At the very least, you’re sure to produce some interesting celfalies… Hehe.

photo 2 (13)

Best of luck to all future Cefaly users! Until there’s a cure, may you always be finding new, effective tools for your migraine toolbox.

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.

  1. Magis D, Sava S, D’Elia T, Baschi R, Schoenen J. Safety and patients’ satisfaction of transcutaneous Supraorbital NeuroStimulation (tSNS) with the Cefaly® device in headache treatment: a survey of 2,313 headache sufferers in the general population. J Headache Pain The Journal of Headache and Pain. 2013;14(1):95. doi:10.1186/1129-2377-14-95.

Comments

  • tlocker
    2 years ago

    SPEND $360. BUY IT. TRY IT. BUT BE AWARE YOU ARE OUT STUCK WITH THE DEVICE FOREVER. You cannot resell it or donate it ANYWHERE (eBay, craigslist, Goodwill, etc), as it is a Medical Device they will not accept listing. So now I have a Medical Device that someone might benefit from sitting under a sink unused. Yes, they have a 60 day trial period; make sure if it isn’t working you don’t try it any longer send it back.

  • anniness
    3 years ago

    I’ve used my Cefaly for 25 days. Anyone notice increases the intensity and frequency of your migraines since you started using it? I’ve noticed that. I don’t know if it’s due to the device.

  • DonnaFA moderator
    3 years ago

    Hi anniness, we’re sorry to hear that you haven’t found any relief. You may be interested in reading some of the articles we have on the site about Cefaly. A few of our contributors have reviewed it as well.

    Thanks for joining the conversation! We’re glad you’re here! -All Best, Donna (Migraine.com team)

  • Bobc2001
    3 years ago

    I am lucky enough to have the VA order one for me. I can’t wait. I also had the VA purchase a Thermazone device. It provide hot or cold water circulation to a variety of patches or masks. It works. Based on Peltier technology. (I’m a computer geek, the technology is a Solid State device.)

  • sarah
    3 years ago

    I’ve been very pleased with my Cefaly, the original. I use it every night in bed as I’m reading before falling asleep. It’s very relaxing and soothes me to sleep. It feels like someone giving you a scalp massage on the front half of your scalp. It also feels like two thumbs applying pressure and massage at the eyebrows. There is also sensations on the forehead. When I started using it, it was very uncomfortable, however, I’ve figured out that the unit must be snapped down onto the electrode. Just resting the unit on top of the electrode can cause a slight stinging sensation.

  • RobertCan
    3 years ago

    I was diagnosed with migraine in 1995. They became “chronic” in 2007. My neurologist prescribed Cefaly in 2014, so I have two years of experience with the device.

    If it did anything to reduce frequency, it would be worth every penny. But that has not been my experience. Admittedly, I was not compliant in that I did not use it on a daily basis. And statistically, many Cefaly users are not considered “compliant” for the same reason. The device emits strong electrical stimulation and it’s not something you look forward to experiencing every day, hence the lack of compliance.

    The good news is that for me, it definitely can reduce the intensity of migraine pain during an attack. The problem was that the minute I stopped using it, the pain returned as strong as ever.

    I’m glad I have it in my migraine toolbox but it’s not something I turn to for every migraine attack. If it were the silver bullett to kill off your migraine, every migraineur would sing its praises from the highest mountain. At best, you’ll hear lukewarm, mixed reviews.

    In the end, I believe it’s worth trying, if you can afford it. Just don’t expect miracles. Best wishes to all.

  • Denise P.
    3 years ago

    I’d like to add that I obtained a Rx from my neurologist and purchased the Canadian model because my son and I wanted to have the ability to change the settings. After using the device as directed for a few weeks, we both found no relief or reduction of our migraines. So I give it a thumbs-down and am sorry that it’s money wasted.

  • Anna Eidt author
    3 years ago

    So sorry to hear that Denise. That’s definitely a risk. I’m glad they offer a money-back guarantee now.

  • James Weil
    3 years ago

    The original version had one of the 2 settings disabled for the US version by order of the FDA. That was an excellent reason to purchase it in Canada. Does anyone know if that will be the case with the new one?

  • Anna Eidt author
    3 years ago

    I think the new one will be the same across the board. I don’t find a big difference between the two settings (I have the Canadian version) except that the abortive mode is a bit more intense. Hopefully the new one will also reach that intensity if desired.

  • GobiBear
    3 years ago

    Just sharing my experience with the Cefaly. I received mine (the Star Trek, headband) in 2014 just before a Rx was required, so it’s the 3 setting version. Compliance as recommended for prevention was a failure for me — setting aside the time to use it, daily, etc. just wasn’t happening. But then I accidentally discovered that nightly use when I have most of my migraines and sleep disruptions worked extremely well for me. I sleep with it next to the bed with baby wipes for cleaning the skin for the electrode and have gotten good at applying the electrode in the dark by feel. It numbs the pain (very soothing), while pain meds are taking effect and after some weeks of use, it began putting me to sleep, which I loved. The loud beeps ARE distracting and the 20 min. chime often woke me up. Also falling asleep with the thing on my head was problematic. SO, I was very pleased to see the new one come out (in the U.S. with Rx) and was one of the first (probably) to purchase it. I’ve been using it for about a month. They’ve tuned the beeping sounds WAY down.. in fact I barely hear them if at all. It still has the blinking light, but I find it handy to know the unit is working as it starts out so gently. I start it and hold my hand in front in order to see the light against my hand and before the unit reaches full strength, I’m usually asleep. It will sometimes fall off during sleep which isn’t a big deal. I find it is as strong as the non Rx version which was one of my concerns. Overall, in over 2 years of almost nightly use, I find my migraines less intense, and of shorter duration. It’s not a miracle, but has worked better than any preventative drugs I’ve tried. I rarely use it during the day, but will with a bad migraine and, again, the Cefaly II is superior for convenience of use, moving around, etc.

  • Anna Eidt author
    3 years ago

    SO GLAD to hear about the quieter beeping! Hooray!

    Glad it’s helped for you. Thanks for sharing.

  • DS3
    3 years ago

    I don’t see this on their website. Is the cephaly II available now? Thanks!

  • Anna Eidt author
    3 years ago

    Hi Diane,

    It’s currently available in the U.S. with a prescription. The U.S. website has information on the latest model. It will be available in Europe soon, and Canada before the year is out I’m told.

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