March 3, 2010 -- A handheld device that magnetically zaps pain may be a promising new treatment for patients with a common type of migraine.
Compared to patients who got sham treatments, more patients treated with the experimental device, known as single-pulse transcranial magnetic stimulation (sTMS), were pain-free two hours later.
About 35 million Americans have migraines, according to the American Headache Society, and about 20% to 30% of these patients have headaches that are preceded by visual or other sensory warning signs.
Known medically as migraine with aura, aura-associated warning symptoms may include seeing flashing lights or zigzag patterns, blind spots or blindness in one or both eyes, a prickling feeling on the skin, and even visual and auditory hallucinations.
Drugs commonly used in the treatment of severe headaches are generally not considered effective in the aura phase of migraine attacks, and many patients want to treat their migraines without using drugs, neurologist and headache specialist Richard B. Lipton, MD, tells WebMD.
Lipton directs the Montefiore Headache Center at the Albert Einstein College of Medicine in the Bronx.
"There is a lot of unmet medical need out there in the treatment of migraine," he says. "Some people don't tolerate the drug treatments very well and others just want to avoid them."
Zapping Migraine Pain
Lipton and colleagues assessed the safety and effectiveness of a portable sTMS device in a study involving 201 migraine-with-aura patients treated at 16 medical centers across the country.
About half the patients were given the sTMS device to use at home. The rest were given an identical looking device that emitted no magnetic pulses.
The idea behind sTMS is that the magnetic pulses disrupt the electrical events in the brain that lead to migraines.
Prior to entering the study, the patients had between one and eight migraines with aura per month.
They were instructed to apply the devices to the back of their heads when they felt a headache coming on, and to administer two pulses.
The patients were also asked to record their pain levels immediately following treatment, and then again 30 minutes, one hour, two hours, 24 hours, and 48 hours later.
Of the 164 patients who recorded migraine attacks during the study, 39% in the sTMS group reported being pain-free two hours after treatment, compared to 22% in the sham group.
No major difference in the severity of migraine-associated light and noise sensitivity and nausea was seen in the two groups.
The study was funded by the medical technology company Neurolieve of Sunnyvale, Calif., which hopes to market the handheld sTMS device as a treatment for migraines with aura, pending FDA approval.
Lipton, who is a past president of the American Headache Society and also owns stock in Neurolieve, points out that the regulatory agency has already approved a similar, non-portable device, which delivers repetitive TMS pulses, for the treatment of depression.
But in an editorial published along with the study, neurologist and migraine researcher Hans-Christoph Diener of Germany's University Hospital Essen writes that important questions remain about the experimental treatment.
These questions include whether the portable sTMS is an effective treatment for patients who have migraine without aura and whether repetitive TMS is more effective than single-pulse TMS.
The study and editorial appear March 4 in the online issue of The Lancet Neurology.
Diener calls for the findings to be replicated in a second, independent trial.
"This is particularly important because the trial failed to show efficacy in a second important endpoint in migraine studies, namely the improvement from moderate headache to mild or no headache," he writes.