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.
