Michigan Head-Pain and Neurological Institute, 3120 Professional Drive, Ann Arbor, MI 48104, USA.
Cephalalgia. 2011 Feb;31(3):271-85. doi: 10.1177/0333102410381142. Epub 2010 Sep 22.
Medically intractable chronic migraine (CM) is a disabling illness characterized by headache ≥15 days per month.
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.
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.
The results of this feasibility study offer promise and should prompt further controlled studies of ONS in CM.
医学上无法治疗的慢性偏头痛（CM）是一种致残性疾病，其特征是每月头痛≥15 天。
进行了一项多中心、随机、双盲、对照可行性研究，以获得枕神经刺激（ONS）治疗 CM 的初步安全性和疗效数据。符合条件的受试者接受枕神经阻滞，反应者随机分为可调节刺激（AS）、预设刺激（PS）或药物治疗（MM）组。
110 名受试者中有 75 名被分配到治疗组；66 名受试者完整记录了日记数据。反应者定义为与基线相比每月头痛天数减少 50%或以上，或平均整体疼痛强度降低 3 分或以上的受试者。AS 的三个月反应率为 39%，PS 为 6%，MM 为 0%。未发生意外不良设备事件。51 名受试者中有 12 名（24%）发生导丝移位。
这项可行性研究的结果令人鼓舞，应该促使进一步开展 ONS 治疗 CM 的对照研究。
