By Pat Anson, Editor
A device that looks like a space age tiara not only helps prevent migraine attacks, but also relieves headache pain once a migraine starts, according to the results of a small clinical trial.
In a study of 20 migraine sufferers, published in The Journal of Headache and Pain, the Cefaly device provided "statistically significant" pain relief, as well as an 81 percent reduction in the number of migraine attacks. Patients in the study also said they used less migraine medication.
Cefaly was approved last year by the U.S. Food and Drug Administration as the first transcutaneous electrical nerve stimulation device specifically authorized for use prior to the onset of migraine pain. Previous studies of the device only focused on migraine prevention.
"This is great confirmation on what we thought about the high efficacy of Cefaly," said Dr. Pierre Rigaux, chief executive officer of Cefaly Technology, a company based in Belgium. "We knew Cefaly to be very safe and with minimal side effects, but now we learn that it's not just the frequency of migraine days that's reduced for every four out of five patients, but the intensity of pain during a migraine attack is reduced as well."
The battery-powered device, which is worn over the forehead like a headband, uses tiny electrical impulses to stimulate the trigeminal nerve, which has been associated with migraine headaches. Cefaly requires a prescription and costs about $349. The device is only available through the company’s website and is not covered by insurance. It’s been available in Europe and Canada for several years.
It was on a trip to Canada that Maria Coder learned about Cefaly and – at the urging of her boyfriend Jay– reluctantly agreed to buy one.
“At the time my boyfriend and I got into a big fight because he wanted me to use it right away and I didn’t really like the idea. I’d never heard of it and I was nervous about using it,” said Coder, who has suffered from migraine for nearly two decades.
The device sat in its box for about a week before she finally tried it.
“I was alone in the apartment and put on the headband and loved it. I fell in love with it. I started to feel better, but I thought beginner’s luck,” Coder told Pain News Network. “I tried it a few more times and then it took on a life of its own. Now I feel like a wimp when I get a migraine because I don’t get them hardly ever compared to before. It’s down to maybe 3 to 5 a month, whereas for almost ten years it was chronic, almost daily.”
Coder, who works in public relations, wrote a letter to Cefaly Technology that eventually turned into a job as a publicist for the company. She also recently married her boyfriend – wearing the Cefaly device for her daily 20-minute session during a break after the ceremony and before her reception.
“I really love and I really believe in it. I didn’t believe in it at first, when I got it. And then the more that I used it, the more I couldn’t deny the results,” she said.
Migraine is thought to affect a billion people worldwide and about 36 million adults in the United States, according to the American Migraine Foundation. It affects three times as many women as men. In addition to headache pain and nausea, migraine can also cause vomiting, blurriness or visual disturbances, and sensitivity to light and sound.
In 2013, the FDA approved the marketing of another device -- the first transcranial magnetic stimulation (TMS) device approved for the relief of migraine pain. The Cerena TMS is placed at the back of the head to release a pulse of magnetic energy to the brain’s occipital cortex, which may stop or lessen pain caused by migraine headaches.