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FDA Approves Cefaly for Migraine Prevention

Cefaly

(i can’t believe I’m posting a selfie with a Cefaly.)

The FDA has approved the Cefaly for migraine prevention in the U.S., according to an announcement from the agency yesterday. Purchasing details aren’t available yet, but it shouldn’t be too long since it is already being manufactured for other countries. It will be available by prescription, which I expect means it will also be covered by insurance. You can order one now at Cefaly.us. The device itself is $295 and a pack of three electrodes costs $25. You must send them your prescription before they will ship your order. I don’t know what this means for eventual insurance coverage.

Here’s an excerpt from the FDA’s press release that describes the studies the approval was based on:

The agency evaluated the safety and effectiveness of the device based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than two migraine headache attacks a month and who had not taken any medications to prevent migraines for three months prior to using Cefaly, as well as a patient satisfaction study of 2,313 Cefaly users in France and Belgium.

The 67-person study showed that those who used Cefaly experienced significantly fewer days with migraines per month and used less migraine attack medication than those who used a placebo device. The device did not completely prevent migraines and did not reduce the intensity of migraines that did occur.

The patient satisfaction study showed that a little more than 53 percent of patients were satisfied with Cefaly treatment and willing to buy the device for continued use. The most commonly reported complaints were dislike of the feeling and not wanting to continue using the device, sleepiness during the treatment session, and headache after the treatment session.

Neither of these studies are new and still have the limitation of being short-term, but I’ll reiterate that it’s worth trying out. Even more so now that you won’t have the additional expense of ordering it from Canada and your insurance may pay for it. I’ll keep you posted on it’s availability.

Here’s my experience with it, including a detailed description of what it feels like:

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Cefaly for Migraine: Diminishing Returns & No Long-Term Relief

My early success with the Cefaly, the external nerve stimulator I told you about last summer, didn’t hold up. I used it for at least an hour a day for six months, over which time my relief from it decreased from three hours a day to no relief at all. None of the published studies on the Cefaly talk about this happening, but none of them studied its use for more than a few months.

The Cefaly can be used to stop migraine attacks in progress (and to stop other types of headaches, according to the manual, though all the published research is on migraine) or as a daily preventive. Since I have (had!) migraines every day, I hoped for both. Not only did I experience diminishing returns of acute relief, I never noticed a preventive effect. Stopping it did not increase my migraine frequency, severity or duration.

I’ve heard from about a dozen of you who tried the Cefaly. No one reported relief even as significant as I had early on and half couldn’t use the device because the sensation in their foreheads was unbearably painful. The Daily Headache readers tend to have chronic and/or severe chronic disorders, so we’re unlikely to be a representative sample. Maybe it’s less effective for people with more severe headache disorders or our propensity toward more significant allodynia (sensitivity to touch) makes it more painful than normal. (If you’re worried it will be painful for you, see if someone you know has a TENS unit you can try. The Cefaly is different than a standard unit in its electrode shape and preset programs, but you’ll get an idea of what it feels like.)

Do I rescind my recommendation? Somewhat surprisingly, no. As long as it’s in your budget (it is returnable, but you’ll be out shipping to and from Canada and a 20% restocking fee), I say go for it. We all respond to different treatments and several headache specialists have told me that even a 10% response rate in early research is encouraging. If you want to explore nerve stimulation without invasive surgery, want a drug-free treatment or haven’t had much luck with standard treatments, the Cefaly is, at the very least, worth a try.

I still have mine and will try it again soon. I’m hopeful that a few months without it will be a sort of reset.

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Nerve Stimulation for Chronic Migraine

Thinking about trying a nerve stimulator to treat chronic migraine? Ask tons of questions beforehand to help ensure you’re making the most informed decision possible. I’ve brainstormed questions to ask your doctor, other patients, and even yourself in Nerve Stimulation: Questions to Ask, my latest post on Migraine.com.

You can learn about my experience with occipital nerve stimulation and what the research says in my posts on Migraine.com from earlier this summer. If you’re curious what I had to say when I still thought mine worked, check out the archive of my nerve simulation posts on The Daily Headache.

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Reviewing the Research on Nerve Stimulation

Curious about nerve stimulation for chronic migraine and what the research has to say? For Nerve Stimulation Research, my latest post on Migraine.com, I pored over all the published research, hoping to summarize it neatly, but the findings are too ambiguous to do so. Instead, I explain some of the reasons why older published studies aren’t generalizable and summarize findings from recent large-scale studies with control groups.

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Cefaly External Neurostimulation Device for Preventing & Aborting Migraine Attacks

Cefaly, an electrical nerve stimulation device that is worn like a headband across the forehead and stimulates the nerves through the skin, is my latest experiment in preventing and aborting migraines. There’s a ton of information to share, so I’m breaking it up into several posts, starting with the basics. If you can’t wait to read about the study, here’s Medscape’s writeup: Neurostimulation Effective in Migraine Prevention. (You can get a login from Bugmenot.)

First off, what the heck is Cefaly? It is basically a TENS unit with an electrode shaped to cover the peripheral branches of the trigeminal nerves in the forehead. Instead of being able to adjust the settings freely as you do on a TENS unit, Cefaly is pre-programmed with three therapeutic settings, one for aborting migraine attacks, one for preventing them, and one for relaxation.

According to Cefaly’s website,

Cefaly treats migraine pain with neurostimulation. A stimulus that limits pain signals from the nerve centre by working on the trigeminal nerve where migraine headaches start. The patented Cefaly treatment changes the trigger threshold of migraine headaches. As the pain threshold becomes harder to reach, migraine headaches are less frequent, less painful, and simply disappear. Cefaly offers patients suffering from migraine pain and headaches an efficient electrotherapeutical system delivered via an extremely comfortable, ergonomic and simple-to-use medical device.

An easy-to-follow marketing video:

Harder to follow without knowledge of scientific terms, this video provides a high-level explanation of the science behind the device:

While the marketing materials focus on migraine (and that’s what my experience represents), the manual recommends its use for tension-type headache, cluster headache, and trigeminal neuralgia. It also claims to reduce stress, promote relaxation, and ease the symptoms of sinusitis, though it does not treat the underlying sinus infection.

Cefaly has not been approved for sale in the US and is is not available here. It is available in Canada, Australia, and Europe. I ordered mine from Costco Canada for $230 USD and had it shipped to a friend in Canada who sent it on to me, though I’m not sure this is strictly legal. My headache specialist said his US patients have ordered it directly from Roxon.ca for $299 USD and Oximetry.ca for $340 USD. Although not inexpensive, $230 is reasonable considering the cost of various preventive and abortive meds.

Replacement electrodes come out to $10 each when shipping is factored in. The life of electrodes is listed at 10 uses in the manual, though reviewers on Costco.ca list various strategies for extending their usefulness. I wash my hands and forehead well before applying the electrode and store it in a Ziploc bag with a cotton ball soaked in alcohol next to it. At 11 uses, my original electrode still seems to be working fine. Even if it costs $1 in electrodes each time I use it, that’s still a savings over what I pay for triptans.

There’s enough hype about Cefaly on the internet that I wouldn’t have even tried it had by headache specialist not recommended it. It just seems too good to be true. At the time I saw my headache specialist in May, he had suggested it to 20 of his patients with intractable chronic migraine and half reported at least some relief from it. One had just written him a letter saying the results were close to miraculous for her. Because I trust my headache specialist immensely, I went for it.

Writing this post, I discovered that headache specialist Alexander Mauskop questions whether Cefaly provides advantages over readily available $50 TENS units. While I could have done with saving some money, I derive comfort from the pre-set programs and am not sure if I could have found the right therapeutic settings on my own. If you already have a TENS unit, it might be worth trying it out on your forehead!

I’m still sorting out the kinks and it is too early to establish any preventive effect, but the device has definitely aborted migraine attacks for me. In Monday’s post, I’ll detail my first week with it.