Background. Vagus nerve stimulation (VNS) paired with rehabilitation may improve upper-limb impairment and function after ischemic stroke. Objective. To report 1-year safety, feasibility, adherence, and outcome data from a home exercise program paired with VNS using long-term follow-up data from a randomized double-blind study of rehabilitation therapy paired with Active VNS (n = 8) or Control VNS (n = 9). Methods. All people were implanted with a VNS device and underwent 6 weeks in clinic therapy with Control or Active VNS followed by home exercises through day 90. Thereafter, participants and investigators were unblinded. The Control VNS group then received 6 weeks in-clinic Active VNS (Cross-VNS group). All participants then performed an individualized home exercise program with self-administered Active VNS. Data from this phase are reported here. Outcome measures were Fugl-Meyer Assessment—Upper Extremity (FMA-UE), Wolf Motor Function Test (Functional and Time), Box and Block Test, Nine-Hole Peg Test, Stroke Impact Scale, and Motor Activity Log. Results. There were no VNS treatment–related serious adverse events during the long-term therapy. Two participants discontinued prior to receiving the full crossover VNS. On average, participants performed 200 ± 63 home therapy sessions, representing device use on 57.4% of home exercise days available for each participant. Pooled analysis revealed that 1 year after randomization, the FMA-UE score increased by 9.2 points (95% CI = 4.7 to 13.7; P = .001; n = 15). Other functional measures were also improved at 1 year. Conclusions. VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.

中文翻译：

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迷走神经刺激与中风后上肢康复相结合：一年随访

背景。迷走神经刺激 (VNS) 与康复相结合可能会改善缺血性中风后的上肢损伤和功能。目标。使用来自康复治疗与主动 VNS 配对的随机双盲研究（n = 8）或控制 VNS (n = 9)。方法。所有的人都植入了 VNS 设备，并接受了 6 周的对照或主动 VNS 临床治疗，然后是第 90 天的家庭练习。此后，参与者和研究人员被揭盲。对照 VNS 组然后接受 6 周的临床活动 VNS（Cross-VNS 组）。然后，所有参与者使用自我管理的 Active VNS 执行个性化的家庭锻炼计划。此处报告该阶段的数据。结果测量是 Fugl-Meyer 评估 - 上肢 (FMA-UE)、Wolf 运动功能测试（功能和时间）、Box 和 Block 测试、九孔钉测试、中风影响量表和运动活动日志。结果。长期治疗期间没有发生与 VNS 治疗相关的严重不良事件。两名参与者在收到完整的交叉 VNS 之前停止使用。平均而言，参与者进行了 200 ± 63 次家庭治疗课程，代表每位参与者在 57.4% 的家庭锻炼天数中使用设备。汇总分析显示，随机化后 1 年，FMA-UE 评分增加了 9.2 分（95% CI = 4.7 至 13.7；P = .001；n = 15）。其他功能措施也在1年时得到改善。结论。VNS结合康复治疗可行，长期依从性好，