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| |  Magnetic Stimulation Offers Potential Non-Drug Treatment Option for Migraine Patients NEW YORK -- March 3, 2010 -- A new hand-held device that delivers a magnetic pulse to the back of the head could be a promising non-invasive, non-drug treatment option for patients with migraine, according to a study published online first and appearing in the April edition of The Lancet Neurology. The device offers effective pain relief for up to 48 hours after treatment in some patients with migraine with aura, without any serious side-effects, when given at the onset of symptoms. Evidence suggests that single-pulse transcranial magnetic stimulation (sTMS) might disrupt the electrical events in the brain that underpin migraine aura. Previous small studies suggest that sTMS reduces migraine pain and that it is well tolerated. However, previous trials used large and expensive devices not suitable for use outside a clinic, and patients were not masked to treatment making it difficult to confirm if the effect of TMS was real. To address these limitations, Richard B Lipton, Albert Einstein College of Medicine, Bronx, New York, and colleagues conducted a randomised, sham-controlled trial to assess the safety and effectiveness of a new, hand-held sTMS device suitable for home use, in the treatment of migraine with aura. A total of 201 patients were randomly assigned to sham stimulation (n = 99) or sTMS (n = 102) and instructed to treat up to 3 attacks over 3 months while experiencing aura, and to record pain and associated symptoms before and at regular intervals after treatment. Findings showed that sTMS was significantly more effective than placebo for the treatment of migraine with aura. More patients were pain free at follow-up intervals of 2, 24, and 48 hours, were free of headache recurrence, and did not require rescue medication, compared with sham stimulation. Of the 164 patients who treated at least 1 attack, 39% in the sTMS group were pain free 2 hours after treatment compared with 22% in the sham group, a therapeutic gain of 17%. Additionally, sTMS treatment did not exacerbate associated symptoms, and was non-inferior to sham stimulation for the improvement of nausea, photophobia, and phonophobia. Importantly, sTMS treatment was well tolerated and no device-related serious adverse events were reported, while incidence and severity of side-effects was low and similar between the 2 groups. Furthermore, patients rarely experienced errors when using the device and rated it an average 8 out of 10 for user-friendliness. “Although the exact mechanisms of migraine remain under study, administration of sTMS in people with migraine with aura decreases progression of the attack in some individuals…and could be a promising acute treatment,” the authors wrote. They concluded by saying that more research is needed to examine the range of sTMS doses and to establish the optimum timing of treatment and cost effectiveness. In an accompanying commentary, Hans-Christoph Diener, MD, University Hospital Essen , Essen, Germany said that the findings show that “the use of TMS could be a major step forward in the treatment of migraine with aura, particularly in patients in whom presently available drug treatment is ineffective, poorly tolerated, or contraindicated.” SOURCE: The Lancet Neurology
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