Kimberley Teresa J, Cramer Steven C, Wolf Steven L, Liu Charles, Gochyyev Perman, Dawson Jesse
Departments of Physical Therapy (T.J.K.), School of Health and Rehabilitation Sciences, MGH Institute of Health Professions, Boston, MA.
Rehabilitation Science (T.J.K., P.G.), School of Health and Rehabilitation Sciences, MGH Institute of Health Professions, Boston, MA.
Stroke. 2025 Aug;56(8):2255-2265. doi: 10.1161/STROKEAHA.124.050479. Epub 2025 May 7.
Persistent upper extremity (UE) impairment is common after stroke. Durable treatment benefits for chronic ischemic stroke are needed. The purpose of this report is to determine the long-term effects of vagus nerve stimulation paired with rehabilitation on impairment, activity, and participation in people with UE impairment after ischemic stroke.
This is a post hoc analysis of data from the VNS-REHAB (A Pivotal Randomized Study Assessing Vagus Nerve Stimulation [VNS] During Rehabilitation for Improved Upper Limb Motor Function After Stroke) randomized clinical trial. Here, we report unblinded, partial crossover, and pooled 1-year outcomes. Initially, 108 participants across 19 sites with chronic ischemic stroke and moderate-to-severe UE impairment were enrolled in VNS-REHAB. Participants received 18 sessions of in-clinic intensive task-specific rehabilitation and 3 months of self-initiated home-based exercise with either real (active) or sham (control) vagus nerve stimulation. Thereafter, Control participants crossed over to receive in-clinic therapy paired with active stimulation. All participants performed home-based exercises paired with self-initiated active stimulation for 1 year. The Fugl-Meyer Assessment UE, Wolf Motor Function Test, and participation outcomes were assessed through 12 months.
Seventy-four participants (69%; 51 male; age, mean±SD, 59.6±8.9) completed 1-year follow-up and provided pooled data through 1 year. At 1 year, compared with baseline, there were improvements in impairment (Fugl-Meyer Assessment UE, 5.23 [95% CI, 4.08-6.39]; <0.001) activity (Wolf Motor Function Test, 0.50 [95% CI, 0.41-0.59]; <0.001) and patient-reported outcomes (Motor Activity Log-Quality of Movement: 0.64 [95% CI, 0.46-0.82], <0.001; Motor Activity Log-Amount of Use: 0.64 [95% CI, 0.46-0.82], <0.001; Stroke Impact Scale-Activities of Daily Living: 7.43 [95% CI, 5.09-9.77], <0.001; Stroke Impact Scale-Hand: 17.89 [95% CI, 14.16-21.63], <0.001; EQ-5D: 5.76 [95% CI, 2.08-9.45], <0.05; and Stroke Specific-Quality of Life: 0.29 [95% CI, 0.19-0.39], <0.001) compared with baseline.
People treated with paired vagus nerve stimulation maintained improvements in UE impairment, activity, participation, and quality-of-life measures at 1 year. Paired vagus nerve stimulation is a Food and Drug Administration-approved, beneficial treatment option for long-term benefit in individuals with chronic UE limitations after ischemic stroke.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03131960.
中风后上肢（UE）持续受损很常见。慢性缺血性中风需要持久的治疗益处。本报告的目的是确定迷走神经刺激与康复相结合对缺血性中风后上肢功能受损患者的功能障碍、活动能力和参与度的长期影响。
这是对VNS-REHAB（一项评估中风后上肢运动功能改善的康复期间迷走神经刺激[VNS]的关键随机研究）随机临床试验数据的事后分析。在此，我们报告了非盲、部分交叉和汇总的1年结果。最初，19个地点的108名患有慢性缺血性中风和中度至重度上肢功能障碍的参与者被纳入VNS-REHAB。参与者接受了18次门诊强化特定任务康复治疗，并进行了3个月的自主居家锻炼，同时接受真正的（活性）或假的（对照）迷走神经刺激。此后，对照组参与者交叉接受门诊治疗并伴有活性刺激。所有参与者进行了1年的自主居家锻炼并伴有自主活性刺激。通过12个月对Fugl-Meyer评估上肢、Wolf运动功能测试和参与度结果进行评估。
74名参与者（69%；51名男性；年龄，均值±标准差，59.6±8.9）完成了1年随访并提供了1年的汇总数据。在1年时，与基线相比，功能障碍（Fugl-Meyer评估上肢，5.23[95%CI，4.08 - 6.39]；<0.001）、活动能力（Wolf运动功能测试，0.50[95%CI，0.41 - 0.59]；<0.001）以及患者报告的结果（运动活动日志 - 运动质量：0.64[95%CI，0.46 - 0.82]，<0.001；运动活动日志 - 使用量：0.64[95%CI，0.46 - 0.82]，<0.001；中风影响量表 - 日常生活活动：7.43[95%CI，5.09 - 9.77]，<0.001；中风影响量表 - 手部：17.89[95%CI，14.16 - 21.63]，<0.001；EQ - 5D：5.76[95%CI，2.08 - 9.45]，<0.05；以及中风特异性生活质量：0.29[95%CI，0.19 - 0.39]，<0.001）均有改善。
接受迷走神经刺激配对治疗的患者在1年时上肢功能障碍、活动能力、参与度和生活质量指标仍保持改善。迷走神经刺激配对是美国食品药品监督管理局批准的，对缺血性中风后慢性上肢功能受限个体具有长期益处的有益治疗选择。
