An experimental handheld device that delivers pulses of magnetic energy to the back of the head may be effective at warding off migraines in some patients, according to a new study funded by the device’s manufacturer.

Health.com
March 04, 2010


(Neuralieve)

By Anne Harding

THURSDAY, March 4, 2010 (Health.com) — Help may be on the way for people who experience migraines but haven't found any relief from pain medications. An experimental handheld device that delivers pulses of magnetic energy to the back of the head may be effective at warding off migraines in some patients, according to a new study funded by the device’s manufacturer.

The technique, known as transcranial magnetic stimulation (TMS), could be the first effective non-drug treatment for the excruciating headaches, as well as the first treatment with the potential to prevent migraine before the pain begins.

The study participants were instructed to give themselves two pulses to the back of the head within an hour after experiencing an aura, the visual disturbances that signal an oncoming migraine in up to 30% of patients.

“I think this device is a really good option for people who want to avoid taking medication, or who have contraindications, side effects, or lack of response to available medications,” says lead study author Richard B. Lipton, MD, a professor of neurology at Albert Einstein College of Medicine, in the Bronx, N.Y.

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Neuralieve, a start-up company based in Sunnyvale, Calif., manufactured the devices used in the study. The company also funded the study, and Dr. Lipton and several of his co-authors have stock options in Neuralieve, or other financial connections to it.

The U.S. Food and Drug Administration (FDA) has not yet approved the device, but if it does earn approval, migraine patients could use it as an alternative to drugs, or in conjunction with medications, Dr. Lipton says.

The FDA has already approved a TMS device to treat depression. Unlike that device, which is heavy and found only in doctor's offices, the migraine device could be used at home.

Dr. Lipton says he’s not sure how much the device would cost, but that people probably would be able to lease or rent it inexpensively, before buying, to see if it worked for them. “Purchasing a device if you don’t know if you’re a responder doesn’t make any sense to me,” he says.

In the study, published in the Lancet, 82 people who suffer from migraines with aura received a TMS device, and the same number received a fake (or "sham") version of the device, which looked—and vibrated—just like the real thing, but did not deliver the magnetic pulses.

Next page: TMS outperformed sham device

Thirty-eight percent of the patients who used the real device had no pain two hours later, compared to 22% of those who used the sham device; they also showed greater pain relief 24 and 48 hours later. According to the study, patients given the device also had measurable reductions in other migraine symptoms, including nausea and sensitivity to light and sound, compared to the sham group.

A comparable percentage of people in each group believed they had received the real device both before and after the treatment, which suggests that the participants did not know which device they had.

“The use of TMS could be a major step forward in patients in whom presently available drug treatment is ineffective, poorly tolerated, or contraindicated,” Hans-Christoph Diener, MD, of University Hospital Essen, in Germany, noted in an editorial accompanying the study. But “many research questions remain unanswered,” he added. For example, it has yet to be seen how many pulses are most effective, whether the device will be cost-effective compared to the widely used migraine drugs called triptans, and whether it’s safe for people with epilepsy.

In migraine with aura, many researchers now believe, a wave of electrical activity begins—usually at the part of the brain responsible for vision in the occipital lobe, at the back of the head—and then spreads forward over the brain’s surface. Animal studies have shown that TMS can stop this process, which is likely why it helps some human migraine sufferers.

“What you’re trying to do is arrest the progress, so to speak,” explains Peter Goadsby, MD, a professor of neurology at the University of California, San Francisco, who was a co-author of the study and has also conducted animal research on TMS. Dr. Goadsby has received research funding from Neuralieve in the past, as well as fees for serving as an adviser to the company.

Right now, Dr. Goadsby points out, there is no treatment that can be given to migraine patients during aura; triptans are no more effective than placebo if they are given during aura, before the migraine itself begins.

Dr. Goadsby adds that even though Dr. Lipton and his colleagues didn't test the device in migraine without aura, the treatment may work for the millions of patients in the U.S. who experience that type of migraine.

Because TMS has already been shown to be safe for the treatment of depression—and at much higher doses (i.e., the number of pulses)—it offers a “gigantic margin of safety" to migraine patients, Dr. Lipton says.

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