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