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.