Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, Università Campus Bio-Medico di Roma, Via Álvaro del Portillo 21, 00128 Rome, Italy.
Fondazione Alberto Sordi-Research Institute for Ageing, Via Álvaro del Portillo 5, 00128 Rome, Italy.
Neural Plast. 2017;2017:7876507. doi: 10.1155/2017/7876507. Epub 2017 Dec 10.
The efficacy of standard rehabilitative therapy for improving upper limb functions after stroke is limited; thus, alternative strategies are needed. Vagus nerve stimulation (VNS) paired with rehabilitation is a promising approach, but the invasiveness of this technique limits its clinical application. Recently, a noninvasive method to stimulate vagus nerve has been developed. The aim of the present study was to explore whether noninvasive VNS combined with robotic rehabilitation can enhance upper limb functionality in chronic stroke. Safety and efficacy of this combination have been assessed within a proof-of-principle, double-blind, semirandomized, sham-controlled trial. Fourteen patients with either ischemic or haemorrhagic chronic stroke were randomized to robot-assisted therapy associated with real or sham VNS, delivered for 10 working days. Efficacy was evaluated by change in upper extremity Fugl-Meyer score. After intervention, there were no adverse events and Fugl-Meyer scores were significantly better in the real group compared to the sham group. Our pilot study confirms that VNS is feasible in stroke patients and can produce a slight clinical improvement in association to robotic rehabilitation. Compared to traditional stimulation, noninvasive VNS seems to be safer and more tolerable. Further studies are needed to confirm the efficacy of this innovative approach.
标准康复疗法改善脑卒中后上肢功能的疗效有限；因此，需要替代策略。迷走神经刺激（VNS）与康复相结合是一种很有前途的方法，但该技术的侵入性限制了其临床应用。最近，已经开发出一种非侵入性刺激迷走神经的方法。本研究旨在探讨非侵入性迷走神经刺激联合机器人康复是否能增强慢性脑卒中患者的上肢功能。在一项原理验证、双盲、半随机、假对照试验中，评估了这种组合的安全性和疗效。14 名缺血性或出血性慢性脑卒中患者被随机分为机器人辅助治疗联合真实或假迷走神经刺激组，治疗 10 个工作日。通过上肢 Fugl-Meyer 评分的变化来评估疗效。干预后，真实组无不良事件，Fugl-Meyer 评分明显优于假刺激组。我们的初步研究证实，VNS 对脑卒中患者是可行的，并且可以与机器人康复联合产生轻微的临床改善。与传统刺激相比，非侵入性 VNS 似乎更安全、更耐受。需要进一步的研究来证实这种创新方法的疗效。
