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Occipital nerve stimulation (ONS) may reduce pain directly within the distribution of the occipital nerve and may lessen activation of the trigeminocervical complex. Open-label studies of ONS for migraine treatment have shown promising results. Investigators have now conducted a blinded safety and feasibility study of ONS, sponsored by the stimulator manufacturer. A total of 75 patients with intractable chronic migraine were randomized, in a 2:1:1 ratio, to receive fully active stimulation with an ONS device, sham stimulation with a device that was active for only 1 minute per day, or continued medical management.
Data on safety and efficacy were available for 66 patients at 3 months. Given the goals of this study, multiple outcomes were ana…