Background. Transcutaneous auricular vagus nerve stimulation (taVNS) is regarded as a potential method for recovery in stroke. The effectiveness of taVNS in acute and subacute stroke should be further discussed as previously, only a few small-scale trials have focused on chronic stroke patients. The objective of this study is to investigate the effect and safety of taVNS on upper limb motor function in subacute ischemic stroke patients. Methods. Twenty-one subacute ischemia stroke patients with single upper limb motor function impairment were enrolled and randomly assigned to conventional rehabilitation training with real or sham taVNS, delivered for 15 consecutive days. Electrodes were fixed to the cymba conchae of the left ear with or without electrical stimulation. Conventional rehabilitation training was performed immediately after the end of real or sham taVNS by the same therapists. Baseline assessments were performed on day 0 of enrollment, and posttreatment evaluations were performed at 15 days, 4 weeks, and 12 weeks after the first intervention. The assessment included the upper limb Fugl-Meyer assessment (FMA-U), the Wolf motor function test (WMFT), the Functional Independence Measurement (FIM), and Brunnstrom stage. Heart rate (HR) and blood pressure (BP) were measured before and after each taVNS intervention. At the same time, any adverse effects were observed during the procedure. Outcomes were assessed by a blind evaluator. Results. There were no significant differences in FMA-U, WMFT, FIM, and Brunnstrom scores between the two groups at baseline (). At the endpoint, the FMA-U, WMFT, and FIM scores were significantly higher than before treatment (), and there was a significantly greater improvement of those measurements in taVNS group compared with sham-taVNS group (). Significant improvements in FMA-U score were found between groups at follow-up. Only one case of skin redness occurred during the study. Conclusions. This study revealed that taVNS appeared to be beneficial to the recovery of upper limb motor function in subacute ischemia stroke patients without obvious adverse effects. Trial registration. This trial is registered with ChiCTR1800019635 on 20 November 2018 (http://www.chictr.org.cn/showproj.aspx?proj=32961).

中文翻译：

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经皮耳廓迷走神经刺激对亚急性缺血性卒中患者上肢运动功能恢复的影响和安全性：一项随机对照研究。

背景。经皮耳迷走神经刺激（taVNS）被认为是中风恢复的潜在方法。taVNS在急性和亚急性中风中的有效性应像以前进一步讨论，只有少数小型试验集中于慢性中风患者。这项研究的目的是研究taVNS对亚急性缺血性中风患者上肢运动功能的影响和安全性。方法。招募了21名单上肢运动功能障碍的亚急性缺血性卒中患者，并随机分配给他们使用真正或假taVNS进行的常规康复训练，连续15天。在有或没有电刺激的情况下，将电极固定在左耳the上。真正的或假的taVNS结束后，立即由同一位治疗师进行常规的康复训练。在入组第0天进行基线评估，并在首次干预后15天，4周和12周进行治疗后评估。评估包括上肢Fugl-Meyer评估（FMA-U），Wolf运动功能测试（WMFT），功能独立性测量（FIM）和Brunnstrom阶段。在每次taVNS干预之前和之后均测量心率（HR）和血压（BP）。同时，在手术过程中观察到任何不良影响。结果由盲人评估者评估。结果。基线时两组之间的FMA-U，WMFT，FIM和Brunnstrom得分无显着差异（）。在终点，FMA-U，WMFT和FIM分数明显高于治疗前（），与sham-taVNS组相比，taVNS组的测量值有显着改善（）。随访时发现各组之间的FMA-U评分有显着改善。在研究期间仅发生一例皮肤发红。结论。这项研究表明，taVNS似乎有利于亚急性缺血性卒中患者的上肢运动功能恢复，而没有明显的不良反应。试用注册。该试验已于2018年11月20日在ChiCTR1800019635上注册（http://www.chictr.org.cn/showproj.aspx?proj=32961）。