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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.

Publication ,  Journal Article
Dawson, J; Engineer, ND; Cramer, SC; Wolf, SL; Ali, R; O'Dell, MW; Pierce, D; Prudente, CN; Redgrave, J; Feng, W; Liu, CY; Francisco, GE ...
Published in: Neurorehabil Neural Repair
June 2023

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.

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Published In

Neurorehabil Neural Repair

DOI

EISSN

1552-6844

Publication Date

June 2023

Volume

37

Issue

6

Start / End Page

367 / 373

Location

United States

Related Subject Headings

  • Vagus Nerve Stimulation
  • Upper Extremity
  • Treatment Outcome
  • Stroke Rehabilitation
  • Stroke
  • Rehabilitation
  • Recovery of Function
  • Motor Disorders
  • Middle Aged
  • Ischemic Stroke
 

Citation

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ICMJE
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Dawson, J., Engineer, N. D., Cramer, S. C., Wolf, S. L., Ali, R., O’Dell, M. W., … Kimberley, T. J. (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. Neurorehabil Neural Repair, 37(6), 367–373. https://doi.org/10.1177/15459683221129274
Dawson, Jesse, Navzer D. Engineer, Steven C. Cramer, Steven L. Wolf, Rushna Ali, Michael W. O’Dell, David Pierce, et al. “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.Neurorehabil Neural Repair 37, no. 6 (June 2023): 367–73. https://doi.org/10.1177/15459683221129274.
Dawson J, Engineer ND, Cramer SC, Wolf SL, Ali R, O’Dell MW, Pierce D, Prudente CN, Redgrave J, Feng W, Liu CY, Francisco GE, Brown BL, Dixit A, Alexander J, DeMark L, Krishna V, Kautz SA, Majid A, Tarver B, Turner DL, Kimberley TJ. 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. Neurorehabil Neural Repair. 2023 Jun;37(6):367–373.
Journal cover image

Published In

Neurorehabil Neural Repair

DOI

EISSN

1552-6844

Publication Date

June 2023

Volume

37

Issue

6

Start / End Page

367 / 373

Location

United States

Related Subject Headings

  • Vagus Nerve Stimulation
  • Upper Extremity
  • Treatment Outcome
  • Stroke Rehabilitation
  • Stroke
  • Rehabilitation
  • Recovery of Function
  • Motor Disorders
  • Middle Aged
  • Ischemic Stroke