Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Institute of Neuroscience and Psychology, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Int J Stroke. 2022 Dec;17(10):1061-1066. doi: 10.1177/17474930221094684. Epub 2022 May 9.
The use of a paired vagus nerve stimulation (VNS) system for the treatment of moderate-to-severe upper extremity motor deficits associated with chronic ischemic stroke has recently been approved by the US Food and Drug Administration. This treatment aims to increase the task-specific neuroplasticity through the activation of cholinergic and noradrenergic networks during rehabilitation therapy. A recent pivotal Phase III trial showed that VNS paired with rehabilitation led to improvements in upper extremity impairment and function in people with moderate-to-severe arm weakness for an average of 3 years after ischemic stroke. The between-group difference following 6 weeks of in-clinic therapy and 90 days of home exercise therapy was three points on the upper extremity Fugl-Meyer score. A clinically meaningful response defined as a greater than or equal to six-point improvement was seen in approximately half of the people treated with VNS compared to approximately a quarter of people treated with rehabilitation alone. Further post-marketing research should aim to establish whether the treatment is also of use for people with intracerebral hemorrhage, in people with more severe arm weakness, and for other post-stroke impairments. In addition, high-quality randomized studies of non-invasive VNS are required.
美国食品和药物管理局最近批准了使用配对迷走神经刺激 (VNS) 系统治疗与慢性缺血性中风相关的中重度上肢运动功能障碍。这种治疗方法旨在通过在康复治疗期间激活胆碱能和去甲肾上腺素能网络来增加任务特异性神经可塑性。最近的一项关键性 III 期试验表明，VNS 与康复治疗相结合，可改善中重度手臂无力患者上肢功能障碍和功能，平均在缺血性中风后 3 年。在 6 周的门诊治疗和 90 天的家庭运动治疗后，上肢 Fugl-Meyer 评分的组间差异为 3 分。接受 VNS 治疗的患者中，约有一半人出现了临床意义上的反应（定义为改善程度大于或等于 6 分），而单独接受康复治疗的患者中，这一比例约为四分之一。进一步的上市后研究应旨在确定该治疗方法是否对脑出血患者、手臂无力更严重的患者以及其他中风后障碍患者也有用。此外，还需要进行高质量的非侵入性 VNS 随机研究。
