Abstract

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.

Highlights

  • Upper limb impairment is a common consequence of stroke with a deep impact on patient’s quality of life

  • Our pilot study confirms that Vagus nerve stimulation (VNS) is feasible in stroke patients and can produce a slight clinical improvement in association to robotic rehabilitation

  • Seven patients were randomized to robot-assisted therapy associated with real tVNS and seven patients to robotassisted therapy associated with sham tVNS

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Summary

Introduction

Upper limb impairment is a common consequence of stroke with a deep impact on patient’s quality of life. Since the efficacy of standard rehabilitative therapy is limited, alternative strategies are needed. Robot-assisted rehabilitation can be useful in stroke patients because it allows an intensive as well as task-specific training characterized by high repetition of movements in a strongly motivating environment [1,2,3]. Several studies have explored the possibility to potentiate the effect of robotic therapy by the association with noninvasive human brain stimulation techniques, such as repetitive transcranial magnetic stimulation (rTMS), that can induce neuroplasticity via long-term potentiation-/depression- (LTP-/LTD-) like phenomena [4]. The evidence in support of this strategy remains low [5, 6]

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