Effect of noninvasive vagus nerve stimulation on acute migraine: An open-label pilot study
Effect of noninvasive vagus nerve stimulation on acute migraine: An open-label pilot study
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DOI：
10.1177/0333102414524494
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发表时间：
2014-10-01
期刊：
影响因子：
4.9
通讯作者：
Simmons, K. A.
中科院分区：
文献类型：
--
作者：
Goadsby, P. J.;Grosberg, B. M.;Simmons, K. A.
背景资料：我们试图评估一种新的，非侵入性的，便携式迷走神经刺激器（nVNS）的急性治疗偏头痛。方法：参与者有偏头痛或无先兆有资格进行开放标签，单臂，多次攻击研究。在六周的时间内，以15分钟的间隔向迷走神经的右颈分支给予两次90秒的剂量，治疗多达四次偏头痛发作。受试者被要求自我治疗中度或重度疼痛，或后20分钟的轻度pain.Results：30名入组患者（25名女性，5名男性，中位年龄39），两个治疗没有攻击，和一个治疗的先兆只有，离开一个完整的分析集27治疗80疼痛发作。13例患者报告了不良事件，特别是：颈部抽搐（n = 1）、声音嘶哑（n = 1）和器械部位发红（n = 1）。未报告非预期、严重或重度不良事件。对于基线时中度或重度头痛的首次治疗发作，两小时的无痛率为19例中的4例（21%）。对于所有中度或重度发作在基线，无痛率为12/54（22%）。结论：nVNS可能是一种有效的和耐受性良好的急性治疗偏头痛在某些患者。
Background: We sought to assess a novel, noninvasive, portable vagal nerve stimulator (nVNS) for acute treatment of migraine.Methods: Participants with migraine with or without aura were eligible for an open-label, single-arm, multiple-attack study. Up to four migraine attacks were treated with two 90-second doses, at 15-minute intervals delivered to the right cervical branch of the vagus nerve within a six-week time period. Subjects were asked to self-treat at moderate or severe pain, or after 20 minutes of mild pain.Results: Of 30 enrolled patients (25 females, five males, median age 39), two treated no attacks, and one treated aura only, leaving a Full Analysis Set of 27 treating 80 attacks with pain. An adverse event was reported in 13 patients, notably: neck twitching (n = 1), raspy voice (n = 1) and redness at the device site (n = 1). No unanticipated, serious or severe adverse events were reported. The pain-free rate at two hours was four of 19 (21%) for the first treated attack with a moderate or severe headache at baseline. For all moderate or severe attacks at baseline, the pain-free rate was 12/54 (22%).Conclusions: nVNS may be an effective and well-tolerated acute treatment for migraine in certain patients.