Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study.
Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study.
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枕神经刺激治疗顽固性慢性偏头痛：ONSTIM 可行性研究。
DOI：
10.1177/0333102410381142
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发表时间：
2011-02
期刊：
影响因子：
--
通讯作者：
ONSTIM Investigators
中科院分区：
文献类型：
--
作者：
Saper JR;Dodick DW;Silberstein SD;McCarville S;Sun M;Goadsby PJ;ONSTIM Investigators
背景：难治性慢性偏头痛（CM）是一种 以每月头痛≥15天为特征的致残性疾病。方法：多中心、随机、盲法、对照 进行可行性研究以获得初步安全性和有效性数据 在CM中进行枕神经刺激（ONS）。合格受试者接受了 枕神经阻滞，应答者随机接受可调节刺激 (AS)预设刺激（PS）或医疗管理（MM）组。结果：110名受试者中有75名被分配到一个 治疗组; 66例患者的完整日记数据可用。应答者被 定义为数量减少50%或以上的受试者 每月头痛天数的%或平均减少三分或更多 与基线相比的总体疼痛强度。三个月应答率为 AS为39%，PS为6%，MM为0%。无非预期 发生了器械不良事件。51例中有12例发生电极导线移位 (24%）的受试者。结论：本可行性研究的结果提供了承诺 并应促进ONS在CM中的进一步对照研究。
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.
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