Faculty of Medicine, University Duisburg-Essen, Essen, Germany.
NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK.
Cephalalgia. 2019 Oct;39(12):1475-1487. doi: 10.1177/0333102419876920. Epub 2019 Sep 15.
Non-invasive vagus nerve stimulation (nVNS; gammaCore®) has the potential to prevent migraine days in patients with migraine on the basis of mechanistic rationale and pilot clinical data.
This multicentre study included a 4-week run-in period, a 12-week double-blind period of randomised treatment with nVNS or sham, and a 24-week open-label period of nVNS. Patients were to administer two 120-second stimulations bilaterally to the neck three times daily (6-8 hours apart).
Of 477 enrolled patients, 332 comprised the intent-to-treat (ITT) population. Mean reductions in migraine days per month (primary outcome) were 2.26 for nVNS (n = 165; baseline, 7.9 days) and 1.80 for sham (n = 167; baseline, 8.1 days) ( = 0.15). Results were similar across other outcomes. Upon observation of suboptimal adherence rates, post hoc analysis of patients with ≥ 67% adherence per month demonstrated significant differences between nVNS (n = 138) and sham (n = 140) for outcomes including reduction in migraine days (2.27 vs. 1.53; = 0.043); therapeutic gains were greater in patients with aura than in those without aura. Most nVNS device-related adverse events were mild and transient, with application site discomfort being the most common.
Preventive nVNS treatment in episodic migraine was not superior to sham stimulation in the ITT population. The "sham" device inadvertently provided a level of active vagus nerve stimulation. Post hoc analysis showed significant effects of nVNS in treatment-adherent patients. PREMIUM; NCT02378844; https://clinicaltrials.gov/ct2/show/NCT02378844.
基于机制原理和初步临床数据，非侵入性迷走神经刺激（nVNS；gammaCore®）有可能预防偏头痛患者的偏头痛发作天数。
这项多中心研究包括 4 周的导入期、12 周的双侧 nVNS 或假刺激随机双盲治疗期以及 24 周的 nVNS 开放标签期。患者每天三次（间隔 6-8 小时）将双侧颈部各进行两次 120 秒的刺激。
在 477 名入组患者中，332 名患者构成意向治疗（ITT）人群。每月偏头痛天数的平均减少量（主要结局）为 nVNS 组（n=165；基线期 7.9 天）2.26，假刺激组（n=167；基线期 8.1 天）1.80（差异=0.15）。其他结局也相似。在观察到依从率不理想后，对每月依从率≥67%的患者进行事后分析显示，nVNS 组（n=138）和假刺激组（n=140）在包括偏头痛天数减少（2.27 与 1.53；差异=0.043）等结局方面存在显著差异；有先兆偏头痛患者的治疗效果优于无先兆偏头痛患者。大多数 nVNS 相关设备不良事件为轻度且短暂，最常见的是应用部位不适。
在 ITT 人群中，预防性 nVNS 治疗在发作性偏头痛中并不优于假刺激。“假”设备无意中提供了一定程度的迷走神经刺激。事后分析显示，治疗依从性高的患者 nVNS 具有显著疗效。 需付费；NCT02378844；https://clinicaltrials.gov/ct2/show/NCT02378844。
