Vagus nerve stimulation paired with rehabilitation for upper limb motor impairment and function after chronic ischemic stroke: subgroup analysis of the randomized, blinded, pivotal, VNS-REHAB device trial

Dawson, J. et al. (2023) Vagus nerve stimulation paired with rehabilitation for upper limb motor impairment and function after chronic ischemic stroke: subgroup analysis of the randomized, blinded, pivotal, VNS-REHAB device trial. Neurorehabilitation and Neural Repair, 37(6), pp. 367-373. (doi: 10.1177/15459683221129274) (PMID:36226541)

Abstract

Background: Vagus Nerve Stimulation (VNS) paired with rehabilitation improved upper extremity impairment and function in a recent pivotal, randomized, triple-blind, sham-controlled trial in people with chronic arm weakness after stroke. Objective: We aimed to determine whether treatment effects varied across candidate subgroups, such as younger age or less injury. Methods: Participants were randomized to receive rehabilitation paired with active VNS or rehabilitation paired with sham stimulation (Control). The primary outcome was the change in impairment measured by the Fugl–Meyer Assessment Upper Extremity (FMA-UE) score on the first day after completion of 6-weeks in-clinic therapy. We explored the effect of VNS treatment by sex, age (≥62 years), time from stroke (>2 years), severity (baseline FMA-UE score >34), paretic side of body, country of enrollment (USA vs UK) and presence of cortical involvement of the index infarction. We assessed whether there was any interaction with treatment. Findings: The primary outcome increased by 5.0 points (SD 4.4) in the VNS group and by 2.4 points (SD 3.8) in the Control group (P = .001, between group difference 2.6, 95% CI 1.03-4.2). The between group difference was similar across all subgroups and there were no significant treatment interactions. There was no important difference in rates of adverse events across subgroups. Conclusion: The response was similar across subgroups examined. The findings suggest that the effects of paired VNS observed in the VNS-REHAB trial are likely to be consistent in wide range of stroke survivors with moderate to severe upper extremity impairment.

• Item Type: Articles
• Additional Information: The trial was funded by MicroTransponder Inc.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Dawson, Professor Jesse
• Authors: Dawson, J., Engineer, N. D., Cramer, S. C., Wolf, S. L., Ali, R., O'Dell, M. W., Pierce, D., Prudente, C. N., Redgrave, J., Feng, W., Liu, C. Y., Francisco, G. E., Brown, B. L., Dixit, A., Alecander, J., DeMark, L., Krishna, V., Kautz, S. A., Majid, A., Tarver, B., Turner, D. L., and Kimberley, T. J.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: Neurorehabilitation and Neural Repair
• Publisher: SAGE Publications
• ISSN: 1545-9683
• ISSN (Online): 1552-6844
• Published Online: 13 October 2022
• Copyright Holders: Copyright © 2022 The Authors
• First Published: First published in Neurorehabilitation and Neural Repair 37(6):367-373
• Publisher Policy: Reproduced under a Creative Commons License