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Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: Results from a randomized, multicenter, double-blinded, controlled study

2012; SAGE Publishing; Volume: 32; Issue: 16 Linguagem: Inglês

10.1177/0333102412462642

1468-2982

Stephen D. Silberstein, David W. Dodick, Joel R. Saper, Billy Huh, Konstantin V. Slavin, Ashwini Sharan, K. L. Reed, Samer Narouze, Alon Y. Mogilner, Jerome Goldstein, Terrence L. Trentman, Julien Vaisman, Joseph Ordia, Christian Weber, Timothy R. Deer, Robert M. Levy, Roni L Diaz, Stephanie N. Washburn, Nagy Mekhail,

Sympathectomy and Hyperhidrosis Treatments

Background: Chronic migraine (CM) is a debilitating neurological disorder with few treatment options. Peripheral nerve stimulation (PNS) of the occipital nerves is a potentially promising therapy for CM patients. Methods: In this randomized, controlled multicenter study, patients diagnosed with CM were implanted with a neurostimulation device near the occipital nerves and randomized 2:1 to active ( n = 105) or sham ( n = 52) stimulation. The primary endpoint was a difference in the percentage of responders (defined as patients that achieved a ≥50% reduction in mean daily visual analog scale scores) in each group at 12 weeks. Results: There was not a significant difference in the percentage of responders in the Active compared with the Control group (95% lower confidence bound (LCB) of −0.06; p = 0.55). However, there was a significant difference in the percentage of patients that achieved a 30% reduction ( p = 0.01). Importantly, compared with sham-treated patients, there were also significant differences in reduction of number of headache days (Active Group = 6.1, baseline = 22.4; Control Group = 3.0, baseline = 20.1; p = 0.008), migraine-related disability ( p = 0.001) and direct reports of pain relief ( p = 0.001). The most common adverse event was persistent implant site pain. Conclusion: Although this study failed to meet its primary endpoint, this is the first large-scale study of PNS of the occipital nerves in CM patients that showed significant reductions in pain, headache days, and migraine-related disability. Additional controlled studies using endpoints that have recently been identified and accepted as clinically meaningful are warranted in this highly disabled patient population with a large unmet medical need. Trial registration: Clinical trials.gov (NCT00615342).