Being migraine-prone is like having an axe hanging over you every day. You know that it could come swooping down at any second, burying itself in your head and bringing excruciating pain. You constantly worry about when the pain will strike again…and more importantly, you ask, What can possibly be done to prevent it?
Well, finally there’s an encouraging answer to that question—because the FDA has just approved the first medical device to prevent migraine headaches. It’s a special type of headband called Cefaly that delivers electric impulses to nerves in the forehead. Now available in the US by prescription, it is completely noninvasive…and its side effects are minimal.
That last attribute is very important because the oral medications available to prevent migraine leave a lot to be desired. They don’t always work that well, and they all can have side effects—fatigue, sleepiness, muscle weakness, nausea, chest pressure, racing heartbeat, tingling or warm sensations, difficulty concentrating, memory problems, sexual problems, liver damage, kidney damage—that can be so intolerable that many sufferers stop taking the drugs.
PUTTING THE NEW DEVICE TO THE TEST
Before it could obtain FDA approval, Cefaly was put through several clinical trials. One recent study included 67 people who had an average of four separate migraine attacks and seven “migraine days” per month, which is typical of migraine patients for whom preventive treatment is deemed appropriate. Some of the migraine patients experienced aura and others did not.
The participants were randomly assigned to use Cefaly or a sham device for 20 minutes each day for 90 days. Both the real device and the sham one looked and sounded the same, and the instructions for use were identical. Cefaly was programmed to deliver electrical impulses of moderate intensity, while the impulses generated by the sham device were very weak and barely perceptible. Neither the participants nor the researchers knew which device each person had.
Starting one month before the study began and continuing to the end of the study period, participants kept daily diaries to record headache frequency and severity. The results…
• 38% of patients using Cefaly experienced at least a 50% improvement in symptoms…but only 12% of the sham group had that level of improvement.
• The number of migraine days per month dropped by 30% in the Cefaly group…but increased by 5% in the sham group.
• Cefaly users decreased their migraine medication by 37%…whereas migraine medication use in the sham group stayed about the same.
• 71% of Cefaly users reported themselves to be moderately or very satisfied with treatment…compared with 39% of those in the sham group.
In a larger study of the device, which is available without a prescription in France, Belgium and Switzerland, researchers gauged satisfaction from people who had rented Cefaly to try it out. Slightly more than half (54%) of the 2,313 users were satisfied enough to purchase Cefaly. Of those who were not satisfied, 4% never turned the device on and 19% used it less than 60 minutes over the course of the 40-day trial period. The most common complaints: 2% of users were not comfortable with the tingling sensation caused by the device…0.5% complained of tension-type headaches after treatment…0.1% had a local allergic reaction to the gel that keeps the electrode attached to the forehead.
The results of these studies, while encouraging, aren’t exactly a home run. For instance, Cefaly is not as effective as topiramate (Topamax), which is one of the more common migraine-prevention drugs on the market. However, the headband has the distinct advantage of causing no serious adverse events—whereas one-quarter of topiramate users stop taking the drug because they find the side effects (described earlier) too difficult to tolerate. The dose of electromagnetic waves generated by Cefaly is weaker than that received while watching TV, the manufacturer said.
SHOULD YOU GIVE THE HEADBAND A TRY?
I called Alan Rapoport, MD, current president of the International Headache Society and a clinical professor of neurology at David Geffen School of Medicine at the University of California, Los Angeles, to get his opinion on Cefaly. Dr. Rapoport is familiar with the device, has tried it himself (though he does not have migraine) and has no financial interest in the company that markets it.
“We need a device like this that may prevent lots of headaches,” Dr. Rapoport told me. “It is too early to know how effective it will be. We have lots of treatments that help when someone is having an acute migraine attack, but finding something that works for prevention without many side effects is more problematic. There are only four such drugs on the market in the US, all of them may cause side effects, and all work for fewer than half of the people who try them. If there is something that’s safe, inexpensive and can really help 38% of migraine sufferers, it should be available for patients to try.”
What causes migraine is not completely understood, but one hypothesis has to do with the trigeminal nerve that carries feelings of touch and pain from the face to the brain. This nerve has several branches, including one ending in the forehead and another ending in the meninges (the covering of the brain). The current thinking is that, in migraine sufferers, this nerve is inflamed and overly responsive to stimulation.
Cefaly relies on transcutaneous electrical nerve stimulation (TENS), an established technology that is already widely used for muscle and nerve pain, to send electric impulses to the trigeminal nerve. The headgear attaches to a self-adhesive electrode placed on the forehead, over the endings of some branches of the trigeminal nerve. Experts aren’t sure exactly how TENS works, but it’s possible that, by stimulating the nerve over and over again with precise pulses, the nerve becomes habituated to the stimulation…which raises the threshold for pain…which in turn reduces the number of migraine attacks. Dr. Rapoport said, “The theory behind the device is that anything you do to the nerve peripherally, meaning outside the brain, could get back to the brain stem and the meninges—and that could change the frequency or severity of migraine.”
Spending 20 minutes each day wearing a battery-powered, pulsing headband to prevent a migraine may be a very worthwhile investment of time for people who normally would spend days each month in extreme pain. Users can go about their daily activities while wearing the device.
Contraindications: According to the manufacturer, Cefaly is not appropriate for people who have implanted metallic hardware (plates, screws, clips) or electronic devices (such as cochlear implants) in the head, nor for those with cardiac pacemakers or implanted or wearable defibrillators. When I asked Dr. Rapoport about using Cefaly during pregnancy, he said, “I would say it is likely to be safe but that a pregnant woman should check with her obstetrician.”
Where to get it: In the US, Cefaly is available by prescription and is approved for patients age 18 and older. The device, which runs on two AAA batteries, costs $295 (plus $29 for shipping and handling)…the electrodes sell for $25 for a pack of three, with each electrode lasting for about 20 sessions. Cefaly can be purchased from the manufacturer and from some pharmacies. Insurance does not cover the cost, though that may change eventually. And Cefaly may seem like a bargain when you consider the expense of time off of work and the high cost of drugs that treat migraine attacks—for instance, the device costs about the same as just six pills of a common migraine medication.
Bottom line: “I’d say it’s worth a try if you need prevention for migraine,” Dr. Rapoport said. “It’s not invasive, it’s not terribly expensive, and it doesn’t seem to have any serious side effects. The tingling in the forehead is usually tolerable. It won’t work for everyone, but if it works for you, that’s great.”
For much more on migraines, including drug-free prevention strategies and treatments, check out our Guide to Migraine Relief.
For Dr. Rapoport’s advice on handling other types of headaches: Read “Surprising Headache Causes…and How to Relieve the Pain.”