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| |  Occipital Nerve Stimulation Shows Promise for the Treatment of Refractory Migraine: Presented at IHS/AHS By Liz Meszaros PHILADELPHIA -- September 13, 2009 -- Occipital nerve stimulation (ONS) may be a safe and effective therapeutic alternative for patients with drug-refractory migraine, according to a study presented on September 12 at the 14th Congress of the International Headache Society & the 51st Annual Scientific Meeting of the American Headache Society (IHS/AHS). However, the results of the study did not reach statistical significance and further study of ONS is called for. “ONS is used as a treatment for chronic migraine, but more evidence for the safety and efficacy of this invasive treatment is needed,” explained lead investigator Richard B. Lipton, MD, The Montefiore Headache Clinic, Albert Einstein College of Medicine, Bronx, New York. “We wanted to conduct a sham-controlled pilot study to gain information for a fully powered study about treatment response subgroups among other factors.” The prospective, double-blind, randomised pilot study included 139 patients who met the 2004 International Classification of Headache Disorders (ICHD-2) criteria for migraine. All patients had failed therapy with a least 2 acute and 2 preventive medications, and all had >=6 days per month of long duration (>=4 hours) migraine with moderate to severe pain. Prior to permanent implant, all subjects received 5 to 10 days of percutaneous trial stimulation with randomised settings to evaluate predictive value on their 12-week outcomes. During the 12-week blinded period, patients were randomised in a 1:1 ratio to receive bilateral active stimulation (250 mcs pulses, 60 Hz, 0-12.7 mA) or sham stimulation (10 mcs pulses, 2 Hz, <1 mA, 1-second-on/90-minutes-off duty cycle). At 12 weeks, all patients were converted to active settings. The primary endpoint of the study, change from baseline in migraine days per month, was evaluated 12 weeks after implantation in 125 subjects, but it did not change significantly from baseline (-5.5 vs -3.9 days/month; P = .29). Response to percutaneous trial stimulation, however, may predict 12-week outcome in patients. Those patients who responded positively to active stimulation reduced migraine days per month by 8.8 days, as compared with 0.7 days in those who responded negatively to stimulation (P < .001). Patients who did not overuse acute medications at baseline (n = 59) also showed a greater treatment effect than those who were medication overusers (n = 66), with -5.9 and -2.6 migraine days per month in the active and control non-overuser groups (P = .13) versus -5.0 and -4.8 days in overuser groups (P = .93). Two-year data showed that the most frequent adverse events were device related infection, non-target area sensory symptoms, and implant site pain. “Though there is a trend in favour of ONS in this pilot study, it did not reach statistical significance compared with sham stimulation. We found that patients who did not overuse symptomatic migraine treatments did better than those with medication overuse,” concluded Dr. Lipton. “Though the results are promising, this treatment is still being studied and has not been approved by the FDA [US Food and Drug Administration].” Funding for this study was provided by Boston Scientific Corporation. [Presentation title: PRISM Study: Occipital Nerve Stimulation for Treatment-Refractory Migraine. Abstract PO47]
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