Safety, feasibility, and efficacy of vagus nerve stimulation paired with upper-limb rehabilitation after ischemic stroke

Dawson, J. et al. (2016) Safety, feasibility, and efficacy of vagus nerve stimulation paired with upper-limb rehabilitation after ischemic stroke. Stroke, 47(1), pp. 143-150. (doi: 10.1161/STROKEAHA.115.010477) (PMID:26645257) (PMCID:PMC4689175)

Abstract

Background and Purpose—Recent animal studies demonstrate that vagus nerve stimulation (VNS) paired with movement induces movement-specific plasticity in motor cortex and improves forelimb function after stroke. We conducted a randomized controlled clinical pilot study of VNS paired with rehabilitation on upper-limb function after ischemic stroke. Methods—Twenty-one participants with ischemic stroke >6 months before and moderate to severe upper-limb impairment were randomized to VNS plus rehabilitation or rehabilitation alone. Rehabilitation consisted of three 2-hour sessions per week for 6 weeks, each involving >400 movement trials. In the VNS group, movements were paired with 0.5-second VNS. The primary objective was to assess safety and feasibility. Secondary end points included change in upper-limb measures (including the Fugl–Meyer Assessment-Upper Extremity). Results—Nine participants were randomized to VNS plus rehabilitation and 11 to rehabilitation alone. There were no serious adverse device effects. One patient had transient vocal cord palsy and dysphagia after implantation. Five had minor adverse device effects including nausea and taste disturbance on the evening of therapy. In the intention-to-treat analysis, the change in Fugl–Meyer Assessment-Upper Extremity scores was not significantly different (between-group difference, 5.7 points; 95% confidence interval, −0.4 to 11.8). In the per-protocol analysis, there was a significant difference in change in Fugl–Meyer Assessment-Upper Extremity score (between-group difference, 6.5 points; 95% confidence interval, 0.4 to 12.6). Conclusions—This study suggests that VNS paired with rehabilitation is feasible and has not raised safety concerns. Additional studies of VNS in adults with chronic stroke will now be performed.

• Item Type: Articles
• Additional Information: The trial was funded entirely by MicroTransponder Inc.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Robertson, Mrs Michele and Dawson, Professor Jesse and Walters, Professor Matthew
• Authors: Dawson, J., Pierce, D., Dixit, A., Kimberley, T. J., Robertson, M., Tarver, B., Hilmi, O., McLean, J., Forbes, K., Kilgard, M. P., Rennaker, R. L., Cramer, S. C., Walters, M., and Engineer, N.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
• Journal Name: Stroke
• Publisher: American Heart Association
• ISSN: 0039-2499
• ISSN (Online): 1524-4628
• Published Online: 08 December 2015
• Copyright Holders: Copyright © 2015 The Authors
• First Published: First published in Stroke 47(1): 143-150
• Publisher Policy: Reproduced under a Creative Commons License