151. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study
- Author
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Saper, Joel R, Dodick, David W, Silberstein, Stephen D, McCarville, Sally, Sun, Mark, and Goadsby, Peter J
- Subjects
Biomedical and Clinical Sciences ,Clinical Sciences ,Chronic Pain ,Pain Research ,Health Services ,Migraines ,Prevention ,Brain Disorders ,Headaches ,Clinical Research ,Neurosciences ,Clinical Trials and Supportive Activities ,Adult ,Chronic Disease ,Double-Blind Method ,Electric Stimulation Therapy ,Electrodes ,Implanted ,Feasibility Studies ,Female ,Humans ,Male ,Middle Aged ,Migraine Disorders ,Peripheral Nerves ,Intractable chronic migraine headache ,chronic migraine headache ,device implantation ,headache days ,occipital nerve stimulation ,ONSTIM Investigators ,Neurology & Neurosurgery ,Clinical sciences ,Biological psychology - Abstract
BackgroundMedically intractable chronic migraine (CM) is a disabling illness characterized by headache ≥15 days per month.MethodsA multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM. Eligible subjects received an occipital nerve block, and responders were randomized to adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.ResultsSeventy-five of 110 subjects were assigned to a treatment group; complete diary data were available for 66. A responder was defined as a subject who achieved a 50% or greater reduction in number of headache days per month or a three-point or greater reduction in average overall pain intensity compared with baseline. Three-month responder rates were 39% for AS, 6% for PS and 0% for MM. No unanticipated adverse device events occurred. Lead migration occurred in 12 of 51 (24%) subjects.ConclusionThe results of this feasibility study offer promise and should prompt further controlled studies of ONS in CM.
- Published
- 2011