Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study

Abstract

Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache ≥15 days per month.Methods: A 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.Results: Seventy-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.Conclusion: The results of this feasibility study offer promise and should prompt further controlled studies of ONS in CM.

Migraine treatment with external trigeminal nerve stimulation: current knowledge on mechanisms

“…Percutaneous nerve stimulation was reported effective for the treatment of various headaches since the 90s (12, 13). Occipital nerve stimulation (ONS) was beneficial for chronic migraine in sham-controlled trials, although the global effect size was modest (14,15,16). The combination of percutaneous ONS and supraorbital nerve stimulation (SNS) was claimed to have a better effect, but randomized controlled trials are lacking (17).…”

Diagnosis, pathophysiology and management of chronic migraine: a proposal of the Belgian Headache Society

“…3 months each) RCT were performed in CM [79][80][81]. The ONSTIM study (n = 66 patients, [80]) showed a reduction of C50 % in headache frequency or a decrease of three points on the intensity scale in 39 % of patients treated with active ONS during 12 weeks, compared to no improvement in the ''non-effectively'' stimulated or medically treated groups. Unfortunately, ONSTIM was not powered to convincingly demonstrate effectiveness of ONS.…”

Headache

“…In this issue, Paemeleire and Bartsch (page 213) discuss occipital nerve stimulation (ONS). There have been two studies of ONS in migraine: ONSTIM 41 and PRISM. 42 Both failed their primary endpoints.…”