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Your Cefaly Questions Answered

The announcement of FDA’s approval of the Cefaly external trigeminal nerve stimulator was exciting, but left migraineurs with tons of questions. Here are answers to a comprehensive list of frequently asked questions. If you have a question that’s not answered here, please leave a comment and I’ll look into it.

Two different studies are referenced in the answers below. One is a clinical study of 67 patients, 30 of whom received a working Cefaly and completed the study.1 The second is a patient satisfaction study with 2,313 participants who rented the device online and were queried about their experience.2 You can read a summary of the research findings in External Nerve Stimulation Device for Migraine Prevention Receives FDA Approval.

Where do I get Cefaly?

You can place an order at www.cefaly.us (be sure to use the .us address, you cannot currently place U.S. orders from Cefaly.com). You will need to send a copy of your prescription before they will send you the device.

Distributors outside the U.S. are not supposed to ship Cefaly to the U.S., but some readers have found companies who will. People have chosen to do this because no prescription is required outside the U.S. and Cefalys from other countries have three different programs (preventive, acute and relaxation), while the U.S. version has only one (preventive). Some readers have reported that devices ordered outside the U.S. have been delayed in customs.

How much does Cefaly cost?

The device itself costs $295 plus $29 for shipping. A three-pack of electrodes is $25 with an additional $5 for shipping.

What forms of payment are accepted?

Currently, the company only accepts payment via PayPal. You cannot pay directly with a credit card.

Will insurance pay for Cefaly?

Cefaly does not have the required billing code for insurance coverage and will not receive one for at least another year. However, some patients have reported that their insurance companies are covering Cefaly as they would any TENS unit. Contact your insurance company directly to verify. If they say no, ask if you can appeal the decision and if a letter of medical necessity from your doctor would increase their chances of approving it. Even you insurance company will cover Cefaly, you will need to pay for it out-of-pocket and submit the receipt for reimbursement.

Is Cefaly returnable?

There is a 60-day money-back guarantee, according to the company. There is also a two year warranty for defective devices.

Is Cefaly for sale at Costco?

No. This question arose because Costco Canada used to sell it, but Costco in the U.S. does not.

Is Cefaly for people with episodic migraine or chronic migraine?

Episodic migraineurs who have two to eight attacks a month are the target market.

Is Cefaly for people who have migraine with aura or migraine without aura?

Recommendations do not distinguish between people who have migraine with aura and migraine without.

Does Cefaly hurt?

All the marketing materials say no. Intolerance to the sensation or pain was reported by 29 people in the patient satisfaction study, which included 2,313 participants. In my entirely unscientific data collection from about a dozen migraineurs, half found the sensation bearably uncomfortable and half found it intolerable. Most of the people I’ve spoken with have chronic migraine, so they could be more sensitive to touch than those with episodic migraine.

What if Cefaly’s intensity is too strong for me?

The program does not start at full intensity, but increases slowly. You can press the button at anytime to stop the intensity from increase beyond that level. There is a slight chance that even the starting intensity will be too uncomfortable for you, but the risk of this is low. With regular use, you are likely to adjust to the sensations of the device.

How long does a person have to use Cefaly to notice an improvement?

On average, it takes two months to notice a reduction in migraine frequency, according to the company. Press materials also say that some users respond in only a couple weeks, others need three months.

Will Cefaly stop a person’s migraine attacks completely?

Patients who received relief from the device in studies reported a reduction in the frequency of their migraines, but not a complete cessation of attacks. They also did not report a reduction in the intensity of their attacks.


 

Can I use Cefaly to stop a migraine attack that’s in process?

FDA approval does not include the use of it as a migraine abortive, only as a preventive therapy. In other countries, it is marketed for both preventing and abortive migraine attacks. Anecdotal evidence indicates that it is an effective migraine abortive for some users.

How effective is Cefaly?

Press materials claim: “In a clinical trial 70% of patients were satisfied with Cefaly. In practice (‘real world’) 81% of regular users are very satisfied.” The 70% satisfaction number comes from a study with 67 participants, 30 of whom used a working device and completed the study. The 81% “real world” satisfaction rate is not mentioned in either published study, but comes from a press release3 about that study. so I don’t know where it comes from or how valid it is. In a study of 2,313 participants, 55% were satisfied enough after an average trial period of 58 days to purchase the device.

Satisfaction is, of course, different than efficacy. In the study of 67 participants, 38% of the 30 patients who received a working device reported at least a 50% reduction in their migraine frequency. About 30% of patients using an active device reported at least a 25% reduction in their migraine frequency. People who received the working device also reported an overall 37% reduction in the amount of acute migraine medication (abortives) they took each month.

The research is promising, but is in no way definitive. Cefaly and its efficacy are still under investigation. If you’re only willing to try a treatment that has a lot of solid evidence behind it, Cefaly isn’t for you. It’s best for people who are OK knowing that it may or may not work and want to see if they’re one of the fortunate ones.

Is Cefaly safe?

All of the side effects reported in studies were “minor and fully reversible,” according to press materials. There were no adverse effects in the study with 67 participants (30 of whom had a working device and completed the study). In the patient satisfaction study, which had 2,313 participants, fewer than 5% reported side effects. Side effects included:

  • intolerance to the buzzing sensation or pain (32 participants)
  • tension-type headache (12 participants)
  • sleepiness during device use (12 participants)
  • insomnia (4 participants)
  • skin irritation (4 participants)
  • allergic reaction at electrode site (2 participants)

The website’s safety section includes graphs with safety data from this larger study. Below the graphs, it says that more than 50,000 units are in use. The layout makes it look like the data reflect the experience of 50,000 users, but it actually only applies to the 2,313 study participants.

Regarding EMFs, the website says, “The dose of electromagnetic waves generated by Cefaly is weaker than that received while watching TV.“

How does Cefaly work?

Cefaly is guided by the same principals as implanted nerve stimulation for migraine, but how the device works it not well understood. 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.4

Cefaly is a transcutaneous electrical nerve stimulator (TENS). The two beliefs behind the use of TENS for pain reduction, according to the American Cancer Society, are that the electrical pulses interrupt pain signals to the brain and/or that they stimulate the body’s production of endorphins, which are natural painkillers.5

Do I need to use Cefaly every day?

Cefaly is intended for daily use for migraine prevention.

How long is each Cefaly treatment session?

The program is 20 minutes long, though you can stop it by removing the device. The FDA approval says that it should be used for no more than 20 minutes each day. However, the Canadian manual says “Cefaly can be used all day long if needed.” Ask your doctor for specific recommendations regarding your  own treatment.

How many programs does Cefaly have?

The device for sale in the U.S. only has one program, as the FDA has only approved it for migraine prevention. Units purchased outside the U.S. have three settings, one for acute treatment of migraine attacks, one for prevention and one for relaxation. On these devices, the intensity of the prevention program falls between that of the acute and relaxation treatments.

How long does an electrode last?

Electrodes are intended for 20 uses if stored in a zip-top bag between use. Some patients have reported extending the life of electrodes by storing them with an alcohol-saturated cotton ball. This worked for me, though the electrode’s conductivity decreased the longer I used it. For the first few months at least, not going beyond 20 uses per electrode will help you determine how effective the device will be for you.

Why is a prescription required?

U.S. regulations require that patients must have a prescription for this device. Why this is different than a typical TENS unit, which you can buy over-the-counter, is unclear.

Is Cefaly available outside of the U.S.?

Yes, Cefaly is for sale in Canada, Australia and Europe, and does not appear to need a prescription anywhere other than the U.S. An internet search with “Cefaly” and the name of your country should bring up places where you can order it.

Is there anyone who shouldn’t use Cefaly?

The company says it should not be used

  • when driving
  • within three months of trauma to the skull or face
  • if you have a rash or skin condition in the area of the forehead where the electrode is placed.
  • if you have are allergic to acrylate.
  • if you have a pacemaker
  • by anyone younger than 18

Can pregnant women use Cefaly?

Women who are pregnant or could become pregnant should check with their doctor before using this device.

Can children use Cefaly?

Cefaly is intended for adults only. The FDA cautions that no one younger than 18 should use it. This is not necessarily because it has shown to be harmful for children, but more likely that it hasn’t been tested on anyone younger than 18.1-5

More Information
Cefaly: A Migraineur’s Review
External Nerve Stimulation Device for Migraine Prevention Receives FDA Approval

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.

  1. Migraine prevention with a supraorbital transcutaneous stimulator: http://www.neurology.org/content/early/2013/02/06/WNL.0b013e3182825055.abstract
  2. 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
  3. Drug-Free Migraine Treatment CEFALY®: Publication of a Study Conducted on 2,313 Patients: http://www.prnewswire.com/news-releases/drug-free-migraine-treatment-cefaly-publication-of-a-study-conducted-on-2313-patients-239246081.html
  4. Neurostimulation Effective in Migraine Prevention: www.medscape.com/viewarticle/778875
  5. Transcutaneous Electrical Nerve Stimulation: http://www.cancer.org/treatment/treatmentsandsideeffects/complementaryandalternativemedicine/manualhealingandphysicaltouch/transcutaneous-electrical-nerve-stimulation

Comments

  • Hotbabe321
    6 months ago

    Has the side effect of vertigo been reported with use of the cefaly

  • Joanna Bodner moderator
    6 months ago

    Hi there @Hotbabe321, I do not believe that vertigo has been a reported side effect. I did however stumble upon a few members in our forums discussing vertigo & cefaly. It is a long thread of comments to scroll through in this link and from some time ago, but you might find these comments helpful to review. If you scroll down a bit, the first comment to call to your attention is from By BayouTigress June 4, 2014 at 1:52 pm & then immediately right under that comment is another discussing vertigo from By LilyB June 9, 2014 at 7:55 pm . Thanks for your question & for reaching out!

  • acholland
    1 year ago

    This article was written in 2014. Ott reads “Cefaly does not have the required billing code for insurance coverage and will not receive one for at least another year.” It’s been four years!
    My question is, has a CPT code been created for the cefaly unit yet?

  • mo
    2 years ago

    I have had migraines for 25 years. They have progressed from a monthly occurrence to now a daily occurrence. I used the first version (headband) with limited success. I am now using the new version and although I’ve only been using it for a month I am experiencing tremendous results. It will often break a headache, and has greatly reduced the number and intensity of the daily headaches. Although you can regulate the strength of the session, I have been using it full strength, hoping to get the most relief. It is a very uncomfortable feeling while it’s working but the results have been well worth it. The discomfort is by far better than having a migraine.

  • Penny
    3 years ago

    I got my Cefaly a week ago, and so far, I cannot tolerate it for more than 5 minutes. In fact, last night it triggered a migraine. Should I keep trying to see if I can get used to it or am I just one of those people who cannot tolerate this particular kind of pain. I have several migraines a week, and I’m really looking for a non-medication solution for relief. Thanks. Penny

  • nham
    3 years ago

    Does Cefaly work for occipital (back of head migraines)? Most my chronic migraines are there. The Arnold kit Cefaly sells is meant for the back of head but not for occipital migraines.

  • jns192 moderator
    3 years ago

    Hi nham,
    Thanks for you question.
    Unfortunately, we are unable to give medical advice online for your safety. However, we encourage you to pose this question to a migraine specialist who would be able to provide you with the best answer.

    In the meantime, I wanted to share our forum on Cefaly. Feel free to read through and/or post to interact with others who have used or are interested in using this device: https://migraine.com/topic/cefaly/

    Best,
    Jillian (Migraine.com Team)

  • Tinker
    3 years ago

    to any of you who have the cefaly band. buy yourself some conductive ultrasound gel and put it on the back of the electrode,once it is not sticky anymore. My electrode has lasted for over 30 days so far and I use it every day. Hope this helps someone save a bit of money on needing to buy these very expensive electrodes.

  • bluebird
    4 years ago

    I have been using the Cefaly for several weeks no. I have chronic daily migraine. I find that I fall asleep with it on and can waken hours later with my body in the same position!I have used it twice a day or in an attempt to interrupt onset. It does not seem to have changed the pattern of Migraine but it does provide a seemingly reliable way to stop and go to sleep. Since sleep wake cycle seems to be part of my problem , this unexpected response feels helpful.This is not a sleepiness exactly but an invitation to deep sleep.

  • half of me
    5 years ago

    Whoops, I see I already posted something about this. Sorry! New at blogging and also have brain issues.

  • half of me
    5 years ago

    Is anyone having trouble buying the Canadian/European device with the three settings? I decided I wanted this device rather than the US-available one. I was able to get it by trying various sellers until I found one that would accept orders to be shipped to the US. It was one of the sellers on amazon.co.uk.

  • tricia67
    5 years ago

    Frustrating news for those of us who waited: Not even a week ago, I tried to buy the device, but was a little short on my PayPal credit. I tried again last night, because a payment I made to PPC finally went through — only to find that cefaly.us is now charging $50 more. I was in tears. I wrote to the company with the faintest of hope that they’d cut me a break since I intended to buy it days ago. I’m sure I don’t have to say what the response was. I had to give in and take the last of my triptans overnight, and now have to cross my fingers that my inevitable subsequent headaches will be mild enough for me to work through, since my editors have long since lost patience with me.

  • half of me
    5 years ago

    I am a first-time reader here. I see some have asked how to obtain the 3-setting Cefaly (sold in Canada, Europe and Australia) if living in the United States. I live in the US and was able to get one. I looked at several non-US websites and most did not take orders to be shipped to the US. I kept looking a various websites, and one of the vendors on amazon.uk took the order and my unit arrived 10 days or so after. I don’t think the package was held up at customs, or at least there was no indication of customs examination on the package. The Cefaly logo was on the outside of the box but no prescription. I did not use a prescription although my headache doctor did write me one. I hope this helps somebody.

  • Karen Curry
    5 years ago

    I would like to try the Cefaly but the web site, http://www.cefaly.us is no longer working. Does anyone know where I can purchase the Cefaly in the United States?

  • Sonya
    5 years ago

    I was reading all the posts on this device a couple hours ago and there were comments posted right up to this afternoon 6/7/2014. Now only comments up to May 22 are showing. How do I get back to the rest of the comments please?

  • Leslie
    5 years ago

    I have used my headband for almost two months now. Treating everyday, sometimes two times a day. — I have chronic migraine pain and have had no relief from any other treatments or medications (and I’ve tried many!!). Unfortunately, I have had no relief from this headband either. It does feel good when I’m wearing it during the treatment however I’ve seen no reduction or relief in the amount of my pain.

    I do hope others have some success with this treatment!!! Good luck!!!

  • Sofie'smom
    5 years ago

    I just got the three-model Cefaly through Amazon Canada, where it is still offered for sale. It came from a medical supply shop in Kuwait, and the instruction book is in English and Arabic. Cefaly has a Middle East Facebook page and it seems that the device has been on sale there since 2010. I was about to try it when I couldn’t wait any longer and had to take a sumatriptan today, so it will have to wait until tomorrow.

  • Diane
    5 years ago

    I am a chronic migraine sufferer and have tried numberous preventatives with limited success. I purchased the European device approximately 2 months ago. I only use for abortive not preventative as I am concerned that could reduce the effectiveness over time however I can say that the abortive setting has been extremely effective for me. I have reduced my painkiller consumption by about 80% and this month I have triptan tabs left when I collected my new prescription, normally I am rationing them the final week before a new prescription. So far I have seen no reduction in the effectiveness of this device. I have also noticed that I do not suffer my normal after effects of a migraine hangover the next day which can be nearly as bad as the migraine and I tend to feel more alert for a couple of days. I have also noticed that I do not tend to get a repeat migraine for up to a week following a cefaly session. It’s early days for me with this device however given even with preventative treatment I was getting migraines 25 days out of 30 and I went for 2 weeks without one this month even if it is a short term relief it is well worth the money. I bought my device from cefaly via amazon.

  • minddoctor
    5 years ago

    So Dr. Cowan @ Stanford is saying that he doesn’t recommend Cefaly due to the fact that his patients have not had success with this method. I’d love to hear from others if this matches your experience or if your symptoms have improved using Ceflay. I am SO tired of more and more medications and it’s certainly disappointing that one of the leading migraine specialists in the country does not believe in this method, which seems to carry such little risk by comparison to some of the medications I’ve tried.

  • Kerrie Smyres moderator author
    5 years ago

    One thing to keep in mind is that patients who go to well-known clinics tend to be those who haven’t had much success with any treatment. They could be a tougher group to treat than the general migraine population, so they may have less success with Cefaly than other people. Even if it only helps 10% of people with migraine, it’d be great if you were one of them.

  • llm
    5 years ago

    I have a metal plate in my forehead from surgery. Would it be dangerous to try the CEFALY? I know a metal plate is probably contraindicated, but is that due to possible ineffectiveness or danger?

  • Kerrie Smyres moderator author
    5 years ago

    I don’t know. You can contact the company directly at info@cefaly.com. Your doctor could also probably give you some guidance.

  • llm
    5 years ago

    Can using the CEFALY, and/or has it been reported, that it can cause Trigeminal Neuralgia?

  • Kerrie Smyres moderator author
    5 years ago

    There’s no research on it for trigeminal neuralgia. Check with your doctor to see if they recommend it. You can also contact the company (info@cefaly.com) and ask if they have any information on its use for trigeminal neuralgia.

  • CathyJ
    5 years ago

    I understand the cefaly uses microcurrents which is a lower power than a Tens Unit….is that correct? And do you know the mesurements for the cefaly and a typical Tens unit. Am curious if a Tens unit would be safe to try?
    A prep pad is said to be used before placing an electrobe. Do you know what kind of pad this is since I’m allergic to alot of pads. Thank you.

  • AmyBritt
    3 years ago

    You do not need to use a pad before applying the electrode to your forehead. The instruction manual clearly says to “wash your forehead”, which I have done using various soaps and had perfectly good conductivity. Hope that helps!

  • Sunny
    4 years ago

    If anyone finds this from an online search –
    You should never put a TENS electrode on your face. Doctors who recommend using a TENS for migraine generally mean that you should put the electrodes on the back of your neck to relieve some of the muscle tightness there. If you apply TENS electrodes to your face, you will cause your facial muscles to twitch uncontrollably.
    The cefaly uses a much, much smaller current. It’s the same theory behind a TENS, but it not a TENS device.

  • Kerrie Smyres moderator author
    5 years ago

    I’m not sure about the microcurrents. I understand Cefaly to work exactly the same as TENS, but I could be wrong.

    Headache specialist Alexander Mauskop recommends that his patients try a TENS unit instead of Cefaly. You can read more about his recommendations by going to his blog, http://www.nyheadache.com/, and searching for Cefaly.

    You can use a cotton ball with alcohol instead of the prep pads. Sometimes I just wash my face before using the device and that seems to work fine.

  • minddoctor
    5 years ago

    I am quite curious about this treatment. I am already on Botox every 3 months and get about one month of good health followed by two months of horrible chronic migraines. I’ve tried many many meds as well, so this seems like it could be a non-pharm, non-invasive possibility. A close friend of mine was involved in the 1st human trials at UCLA using TENS for depression – it actually CURED his lifelong illness, and research is starting to show a very high efficacy rate (for depression). One thing to note is that it’s only effective for mood when you use it at the right location, frequency, and duration. Makes me wonder if it’s not the same for chronic migraines? In other words, perhaps buying a cheap TENS and just using it without the accurate frequency could explain why it may not be working for some? Here’s hoping that there’s something to this thing. I’ve written to Dr. Cowan at Stanford to get his opinion and will get back to you all on what he thinks.

  • Kerrie Smyres moderator author
    5 years ago

    That’s interesting speculation. I’m not sure anyone knows how much (or if) those details matter for migraine. Headache specialist Alexander Mauskop mentioned in a comment on this post that he recommends a TENS unit instead of Cefaly because it gives patients more control over the current, frequency of stimulation and duration.

  • Piglet
    5 years ago

    I live in the U.S. but I bought Cefaly in Canada about 9 months ago, on the suggestion of my U.S. certified migraine specialist. I have severe chronic migraines and it worked really well for about six weeks (preventing, thwarting, reducing, you name it). I found it a little uncomfortable at first, but nothing compared to, say, Botox. I used it on all of the settings, including daily preventative. Really, it was a miracle for me. And then, it became less and less effective. I tried changing the electrodes, batteries, cleaning the contacts, etc. to no avail. The migraine specialist told me to take a break as this is common with all migraine treatments at some point. So I am waiting a few months to see if I get the good juju back. I may even buy a second unit to determine if my original might have a defect. I cannot speak for the U.S. version, which seems rather limited in its settings, but the bottom line is, that was the best six weeks I have had in years, and I would definitely go the $300 bucks even knowing that it wouldn’t last.

  • Kerrie Smyres moderator author
    5 years ago

    Thanks for sharing your story. Please let us know if it works when you try it again.

    I’m in a similar position (although mine never worked as well as yours did) — it helped at first, then the relief diminished slowly over six months of use until it was completely ineffective. I’m taking a break and will try it again soon.

  • Dr. Alex Mauskop
    5 years ago

    My patients haven’t had much success with Cefaly. To save them money, I suggest that they try a regular TENS unit, which can costs as little as $50. It is not as cool-looking or convenient, but it offers more options in adjusting the current, frequency of stimulation and duration.

  • Kerrie Smyres moderator author
    5 years ago

    Thanks for the information, Dr. Mauskop. Several people have asked me about doing that, but are afraid to try because of dire warnings not to use TENS units on the head. Do you recommend a specific setting to start?

  • onehsancare
    5 years ago

    What activities can you do during the Cefaly treatment? Read? Watch TV? Nap? Crossword puzzle? Meditate? Those are all different levels of brain use.

  • Kerrie Smyres moderator author
    5 years ago

    I don’t think the level of brain activity matters, just that you’re not leaning forward while you do it (that causes the device to lose connection with the electrode and stop working). I mostly read while using mine, but watched TV a couple times and sometimes napped.

  • marlenerossman
    5 years ago

    I bought the Cefaly through Canada where it had been approved eariler.

    It was USELESS, completely useless.

  • Kerrie Smyres moderator author
    5 years ago

    I’m so sorry to hear that. I continue to hear from chronic migraineurs who had no success with it. That’s too bad, since it seems chronic migraineurs have the most interest in trying it.

  • HorseAndCarriage
    5 years ago

    So, does it work for chronic migraines or not? Does it work on silent migraines?

  • Kerrie Smyres moderator author
    5 years ago

    No one knows for sure on either point. It hasn’t been tested specifically for chronic migraine, although some study participants may have met the chronic migraine diagnosis criteria. The studies also have not considered its use for migraines without head pain.

  • Pat
    5 years ago

    Is there anywhere I can rent this device before buying? Also, by your description, the Eu or Canadian version sounds like it would be much more useful – can I order that one?
    I tried TENS years ago to no relief and hope this new device is different, but would like to ‘borrow’ one first to check it out.

  • Kerrie Smyres moderator author
    5 years ago

    I’ve received confirmation from a company representative that there is not rental program in the U.S.

  • Kerrie Smyres moderator author
    5 years ago

    I don’t believe you can rent it, but you have 60 days to return it if it doesn’t work. You’d only be out the cost of shipping both ways. (I’m checking with the company to verify that there is not a rental program. I’ll let you know when I hear back.)

    Companies that sell the device in other countries are not supposed to ship them to the U.S., but some might. You’d have to check with specific companies to see if they will ship to you. If you have a friend in one of the other countries where it is available, you could have it shipped to them, then have them ship it to you.

  • gail
    5 years ago

    It appears that although targeted for episodic it helps chronic migraines also. Please confirm. Thanks.

  • Kerrie Smyres moderator author
    5 years ago

    There’s no published research on whether or not it helps with chronic migraine. Anecdotally, chronic migraineurs I know have either found it too painful to use or to be helpful for aborting migraine attacks, but not preventing them. Migraine.com will soon publish a detailed review that I wrote about using it for chronic migraine.

  • Poll