Efficacy and Safety of Vagus Nerve Stimulation in Stroke Rehabilitation: A Systematic Review and Meta-Analysis

Well you blithering idiots it has been proven to work a long time ago.  All your mentors and senior researchers had to do was to tell you to create a protocol on this and get it distributed to all 10 million yearly stroke survivors  now and into the future. And they completely failed at their job, thus wasting all this time and money.

• vagus nerve (59 posts to July 2012)

Efficacy and Safety of Vagus Nerve Stimulation in Stroke Rehabilitation: A Systematic Review and Meta-Analysis

Cerebrovasc Dis

https://doi.org/10.1159/000526470

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Abstract

Introduction: Recent randomized controlled trials (RCTs) have assessed the role of vagus nerve stimulation (VNS) when paired with standard rehabilitation in stroke patients. This review aimed to evaluate the efficacy and safety of VNS as a novel treatment option for post-stroke recovery.  

Methods: 

We searched PubMed, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL), and CINAHL Plus for articles published from their date of inception to June 2021. RCTs investigating the efficacy or safety of VNS on post-stroke recovery were included. The outcomes were upper limb sensorimotor function, health-related quality of life, level of independence, cardiovascular effects, and adverse events. The risk of bias was assessed using the Cochrane risk-of-bias tool, while the certainty of the evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) criteria. Review Manager 5.4 was used to conduct the meta-analysis.  

Results: 

Seven RCTs (n = 236 subjects) met the eligibility criteria. Upper limb sensorimotor function, assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), improved at day 1 (n = 4 RCTs; standardized mean difference [SMD] 1.01; 95% confidence interval [CI]: 0.35–1.66) and day 90 post-intervention (n = 3 RCTs; SMD 0.64; 95% CI: 0.31–0.98; moderate certainty of evidence) but not at day 30 follow-up (n = 2 RCTs; SMD 1.54; 95% CI: −0.39 to 3.46). Clinically significant upper limb sensorimotor function recovery, as defined by ≥6 points increase in FMA-UE, was significantly higher at day 1 (n = 2 RCTs; risk ratio [RR] 2.01; 95% CI: 1.02–3.94) and day 90 post-intervention (n = 2 RCTs; RR 2.14; 95% CI: 1.32–3.45; moderate certainty of the evidence). The between-group effect sizes for upper limb sensorimotor function recovery was medium to large (Hedges’ g 0.535–2.659). While the level of independence improved with VNS, its impact on health-related quality of life remains unclear as this was only studied in two trials with mixed results. Generally, adverse events reported were mild and self-limiting.  

Conclusion: 

VNS may be an effective and safe adjunct to standard rehabilitation for post-stroke recovery; however, its clinical significance and long-term efficacy and safety remain unclear.(Really?)

© 2022 The Author(s). Published by S. Karger AG, Basel

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Introduction

Stroke is often associated with a significant disease burden requiring substantial treatment, especially post-stroke care [1]. Most survivors suffer from neurological deficits and require around-the-clock care or institutionalization due to limited functional independence [2]. Rehabilitation is an important component of post-stroke care. The goal of rehabilitation is to provide extensive education and task-specific training to maximize functional abilities, thus improving the level of independence. Physical rehabilitation facilitates synaptic plasticity and cortical reorganization within the motor cortex [3].

Over the years, several large randomized controlled trials (RCTs) of increased rehabilitation regime, the use of rehabilitation devices, and brain stimulation therapies devices have not demonstrated clinically meaningful motor recovery compared to standard rehabilitation therapy only [4, 5]. Several preclinical trials have reported favourable post-stroke recovery following combined vagus nerve stimulation (VNS) and rehabilitation therapy, and several clinical trials have shown promising results [6-8]. VNS is a technique that provides stimulations to the vagus nerve via an implantable device or a non-implantable device attached to the skin overlying the vagus nerve [9, 10]. The enhanced rehabilitation model is postulated to induce a brain environment that might increase the potential for experience-dependent plasticity [11]. A recent meta-analysis of animal studies highlighted that combined VNS and rehabilitation therapy facilitated clinically significant motor function recovery following neurological injuries [10]. This study aimed to systematically review the efficacy and safety of VNS on post-stroke recovery.

Ananda R.a,b · Roslan M.H.B.a · Wong L.L.a · Botross N.P.a · Ngim C.F.a · Mariapun J.a Author affiliations Corresponding Authors Keywords: StrokeRehabilitationNeurorehabilitationVagus nerve stimulation

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