Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up

Jesse Dawson, Navzer D. Engineer, Cecília N. Prudente, David Pierce, Gerard Francisco, Nuray Yozbatiran, W. Brent Tarver, Reema Casavant, Danielle K. Kline, Steven C. Cramer, Ann Van de Winckel, Teresa J. Kimberley

Research output: Contribution to journalArticlepeer-review

Abstract

Background. Vagus nerve stimulation (VNS) paired with rehabilitation may improve upper-limb impairment and function after ischemic stroke. Objective. To report 1-year safety, feasibility, adherence, and outcome data from a home exercise program paired with VNS using long-term follow-up data from a randomized double-blind study of rehabilitation therapy paired with Active VNS (n = 8) or Control VNS (n = 9). Methods. All people were implanted with a VNS device and underwent 6 weeks in clinic therapy with Control or Active VNS followed by home exercises through day 90. Thereafter, participants and investigators were unblinded. The Control VNS group then received 6 weeks in-clinic Active VNS (Cross-VNS group). All participants then performed an individualized home exercise program with self-administered Active VNS. Data from this phase are reported here. Outcome measures were Fugl-Meyer Assessment—Upper Extremity (FMA-UE), Wolf Motor Function Test (Functional and Time), Box and Block Test, Nine-Hole Peg Test, Stroke Impact Scale, and Motor Activity Log. Results. There were no VNS treatment–related serious adverse events during the long-term therapy. Two participants discontinued prior to receiving the full crossover VNS. On average, participants performed 200 ± 63 home therapy sessions, representing device use on 57.4% of home exercise days available for each participant. Pooled analysis revealed that 1 year after randomization, the FMA-UE score increased by 9.2 points (95% CI = 4.7 to 13.7; P =.001; n = 15). Other functional measures were also improved at 1 year. Conclusions. VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.

Original languageEnglish (US)
Pages (from-to)609-615
Number of pages7
JournalNeurorehabilitation and Neural Repair
Volume34
Issue number7
DOIs
StatePublished - Jul 1 2020

Bibliographical note

Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The trial was funded by MicroTransponder Inc. The funders had no responsibility in the acquisition and analysis of the data, nor in the decision to submit the results for publication.

Publisher Copyright:
© The Author(s) 2020.

Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.

Keywords

  • neuromodulation
  • rehabilitation
  • stroke
  • vagus nerve

PubMed: MeSH publication types

  • Journal Article
  • Research Support, Non-U.S. Gov't

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