Safety and Satisfaction of Cefaly (Headband TENS) for Headaches

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. 2013 Dec 1;14:95. doi: 10.1186/1129-2377-14-95. Magis D, Sava S, d’Elia TS, Baschi R, Schoenen J.

Transcutaneous supraorbital nerve stimulation (tSNS) with the Cefaly® device was recently found superior to sham stimulation for episodic migraine prevention in a randomized trial. Its safety and efficiency in larger cohorts of headache sufferers in the general population remain to be determined.The objective of this study was to assess the satisfaction with the Cefaly® device in 2,313 headache sufferers who rented the device for a 40-day trial period via Internet.
Only subjects using specific anti-migraine drugs, and thus most likely suffering from migraine, were included in the survey. Adverse events (AEs) and willingness to continue tSNS were monitored via phone interviews after the trial period. A built-in software allowed monitoring the total duration of use and hence compliance in subjects who returned the device to the manufacturer after the trial period.
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. Ninety-nine subjects out of the 2,313 (4.3%) reported one or more AEs, but none of them was serious. The most frequent AEs were local pain/intolerance to paresthesia (47 subjects, i.e. 2.03%), arousal changes (mostly sleepiness/fatigue, sometimes insomnia, 19 subjects, i.e. 0.82%), headache after the stimulation (12 subjects, i.e. 0.52%). A transient local skin allergy was seen in 2 subjects, i.e. 0.09%.
This survey of 2,313 headache sufferers in the general population confirms that tSNS with is a safe and well-tolerated treatment for migraine headaches that provides satisfaction to a majority of patients who tested it for 40 days. Only 4.3% of subjects reported AEs, all of them were minor and fully reversible.

My comments:

What I like was they demonstrated the safety of non-invasive supraorbital (forehead above the eyes) electric stimulation for headaches and found minimal, mild, and no serious side effects on 2313 patients.  That is by far the largest population I have seen tested with any form of electric stimulation. They gave reasonably clear parameters with regards to TENS protocol used: a biphasic rectangular waveform, pulse duration of 250 uS, 60 Hz, and maximum intensity of 16 mA to be used 20 minutes per day, daily. Initially I thought those parameters sounded weak, but when programming my own electric stimulation machines (both my Genesy 1100 and EV-906) to the same parameters , 16 mA turns to be pretty strong when electrodes are placed over the forehead. I’m very electric stimulation tolerant and was able to get to 16 mA without much trouble, but it felt intense. My office staff, all of which are female and some of which get headaches, were only able to tolerate 5-7 mA before being limited by pain/discomfort. So, I don’t think weakness of the machine is a problem in the study. I think supraorbital and supratrochlear nerves being very close to the skin surface are relatively easy to reach with TENS and thus don’t need an especially powerful stimulator.

They didn’t give any data with regards to how well the machine worked except that 54.4% said they were happy enough to purchase it at $246 Euros over the rental costs during the study (full price was 295 Euros).  However, there was no data given with regards to headache intensity, frequency, or disability over the course of the study. I would think that kind of data would be easy to gather with a survey, and though there was no control group it would be interesting to see if and how much the changes were from pre- to post-treatment for such a large number of people. To be fair, the same group of authors did give such data in another study, on a much smaller number of subjects.  I intend to review that next, but it would have been good to see some additional outcome data on this larger group.

Criticisms aside, I like the study. It gives great safety information and got FDA approval on some specific TENS outputs and pad placements that I can incorporate into my own electric stimulation treatments and research. I do suspect that outcomes could be improved by incorporating suboccipital (back of the neck) stimulation with the supraorbital stimulation.  That is proving to be the most effective for chronic migraines headaches in the peripheral nerve stimulation studies, which I am currently gathering data on.

Thanks for reading my blog. If you have any questions or comments (even hostile ones) please don’t hesitate to ask/share. If you’re reading one of my older blogs, perhaps unrelated to neck or back pain, and it helps you, please remember SpineFit Yoga for you or someone you know in the future.

Chad Reilly is a Physical Therapist, obtaining his Master’s in Physical Therapy from Northern Arizona University. He graduated Summa Cum Laude with a B.S. Exercise Science also from NAU. He is a Certified Strength and Conditioning Specialist, and holds a USA Weightlifting Club Coach Certification as well as a NASM Personal Training Certificate. Chad completed his Yoga Teacher Training at Sampoorna Yoga in Goa, India.


5 responses to “Safety and Satisfaction of Cefaly (Headband TENS) for Headaches”

  1. Jeff Fried

    I’ve been using the US FDA approved version for 11 days. It uncovered, and brought into remission, a low grade, somewhat consistent, migraine. My one concern with using the device is that i had Premature Vitriol Detachment from cataract surgery about 5 years ago and i wonder at the pressure that may occur on my eye during the procedure. Could it cause further PVDs or even retinal detachment that is sometimes associated with PVDs. I didn’t find anything when searching the web, but that still hasn’t lessened my concern.

    1. Chad Reilly

      Good question. I did a search to see if there was any research or case studies regarding electric stimulation and PVD or retinal detachment and came up with nothing. I would expect it’s safe but it might be a good idea to bring the device to your ophthalmologist and see if he can test for any stress while you use it. I would expect nobody is going to just know offhand if there would be any effects, and likely there wouldn’t be, but nobody is going to want to open themselves up to liability by saying it’s perfectly safe. Maybe also contact Cephaly direct:

  2. Jeff Fried

    Thanks, Chad, i did bring the PVD up with my Stanford Opthalmologist. He said that once the PVD had taken place there wouldn’t be an issue since the vitreous fluid will not re-attach. While this physician knew my history, i forgot to ask explicitly about possible problems due to the cataract surgery replacement itself, so i’m going back to ask that question.

  3. Leha Carpenter

    Hi, Chad: I’m wondering if this placement and some light EMS could be used to counter the effects of an over-zealous application of Botox that I believe may have partially atrophied the forehead area of my frontalis muscle? My eyebrows dropped after injection (was not supposed to happen), and now the outer corners remain mostly down, except on one side where some muscle tone seems to have returned. I have a Roscoe combination TENS, EMS, Microcurrent, and IF device, but really don’t know what I’m doing.

    Please, if you have a moment, I would greatly value your thoughts on this. Thank you.


    1. Chad Reilly

      Hi Leha,

      Sorry for getting back to you late. I was in India for a month training in yoga, and my internet reception wasn’t the best. If I had botox induced muscle atrophy EMS would be on the short list of things I would try. EMS to the frontalis muscle should and within reasonable parameters should be safe. It’s exactly where they place the electrodes in the Cefaly research, which I expect you probably noticed.

      Which Roscoe unit? The TwinStim4? If it’s the 4th model with biphasic symmetric square wave current, and it’s programmable it should work great. If it’s one of their older models with monophasic current I would be concerned about the risk of burns if you try and turn it up enough to strengthen muscle.

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