Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke.
Safety, Feasibility, and Efficacy of Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Ischemic Stroke.
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DOI：
10.1161/strokeaha.115.010477
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发表时间：
2016-01
期刊：
影响因子：
8.3
通讯作者：
Engineer N
中科院分区：
文献类型：
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作者：
Dawson J;Pierce D;Dixit A;Kimberley TJ;Robertson M;Tarver B;Hilmi O;McLean J;Forbes K;Kilgard MP;Rennaker RL;Cramer SC;Walters M;Engineer N
补充数字内容可在文本中找到。最近的动物研究表明，迷走神经刺激（VNS）与运动配对诱导运动皮层的运动特异性可塑性，改善中风后前肢功能。我们进行了一项随机对照的临床初步研究，迷走神经刺激结合康复治疗对缺血性脑卒中后上肢功能的影响。21名缺血性卒中>6个月且上肢中度至重度损伤的参与者被随机分为VNS加康复组或单纯康复组。康复治疗包括每周3次2小时的治疗，持续6周，每次治疗包括>400次运动试验。在VNS组中，运动与0.5秒VNS配对。主要目的是评估安全性和可行性。次要终点包括上肢测量的变化（包括Fugl-Meyer评估-上肢功能）。9名参与者随机接受VNS加康复治疗，11名参与者仅接受康复治疗。无严重器械不良反应。1例患者在植入后出现一过性声带麻痹和吞咽困难。5例患者在治疗当晚出现轻微器械不良反应，包括恶心和味觉障碍。在意向性治疗分析中，Fugl-Meyer评估上限评分的变化无显著差异（组间差异，5.7分; 95%置信区间，-0.4至11.8）。在符合方案分析中，Fugl-Meyer评估-上限评分的变化存在显著差异（组间差异，6.5分; 95%置信区间，0.4 - 12.6）。这项研究表明，迷走神经刺激与康复相结合是可行的，并没有引起安全性问题。现在将在成人慢性卒中患者中进行更多的VNS研究。URL：https://www.clinicaltrials.gov。唯一标识符：NCT 01669161。
Supplemental Digital Content is available in the text. Recent animal studies demonstrate that vagus nerve stimulation (VNS) paired with movement induces movement-specific plasticity in motor cortex and improves forelimb function after stroke. We conducted a randomized controlled clinical pilot study of VNS paired with rehabilitation on upper-limb function after ischemic stroke. Twenty-one participants with ischemic stroke >6 months before and moderate to severe upper-limb impairment were randomized to VNS plus rehabilitation or rehabilitation alone. Rehabilitation consisted of three 2-hour sessions per week for 6 weeks, each involving >400 movement trials. In the VNS group, movements were paired with 0.5-second VNS. The primary objective was to assess safety and feasibility. Secondary end points included change in upper-limb measures (including the Fugl–Meyer Assessment-Upper Extremity). Nine participants were randomized to VNS plus rehabilitation and 11 to rehabilitation alone. There were no serious adverse device effects. One patient had transient vocal cord palsy and dysphagia after implantation. Five had minor adverse device effects including nausea and taste disturbance on the evening of therapy. In the intention-to-treat analysis, the change in Fugl–Meyer Assessment-Upper Extremity scores was not significantly different (between-group difference, 5.7 points; 95% confidence interval, −0.4 to 11.8). In the per-protocol analysis, there was a significant difference in change in Fugl–Meyer Assessment-Upper Extremity score (between-group difference, 6.5 points; 95% confidence interval, 0.4 to 12.6). This study suggests that VNS paired with rehabilitation is feasible and has not raised safety concerns. Additional studies of VNS in adults with chronic stroke will now be performed. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01669161.