Upper extremity motor outcomes during paired vagus nerve stimulation in chronic ischemic stroke: a retrospective single-health-system cohort study.

Authors

Ronald Benitez, Michelle Darling, Paige Zaorski, Quinn Galligan, Jack Maurer, Nicole McNamara, Shannon J Doherty

Published in

Frontiers in neurology. Volume 17. Pages 1872498. Epub Sep 30, 2026.

Abstract

Persistent upper extremity (UE) impairment after stroke is a major cause of long-term disability, and treatment options in the chronic phase are limited. In randomized trials, vagus nerve stimulation paired with task-specific rehabilitation (Paired VNS) produced greater improvement in UE function and activity than the same rehabilitation with sham stimulation, leading to FDA approval in 2021.
We conducted a retrospective, observational cohort study of adults with chronic stroke and persistent UE deficits who underwent Vivistim implantation and participated in a Paired VNS program delivered across 5 outpatient clinics within our health system. The primary outcome was change in Fugl-Meyer Assessment-Upper Extremity (FMA-UE) from baseline (Paired VNS therapy initiation) to end of the intended Paired VNS therapy protocol (18 sessions). A ≥6-point improvement defined a clinically meaningful response. Adverse events were a secondary safety outcome, ascertained from routine clinical documentation and not systematically collected beyond early postoperative follow-up.
32 patients underwent device implantation; 28 (88%) completed the intended protocol within the health system and had paired FMA-UE assessments available for the primary analysis. Ages ranged from 34 to 81 years (mean 62.1) and the median time since stroke was 3.0 years (IQR 1.7-4.2). FMA-UE scores improved for all 28 local completers. The mean increase of 9.43 points was statistically significant (95% CI 7.20-11.66; p < 0.001), the median increase was 8.0 points (IQR 5.0-13.25) and 20 patients (71.4%; 95% CI 52.9-84.7%) achieved a clinically meaningful response. Chart-derived clinical notes provided illustrative context regarding individual changes in daily activities that accompanied UE motor improvement in selected cases. Among the 32 implanted patients, one postoperative hematoma resolved without intervention and one device was explanted after 410 days due to chest tingling.
In this retrospective single-health-system cohort, Paired VNS was associated with significant improvement in FMA-UE scores among 28 local completers. The findings are directionally consistent with prior trial evidence.

PMID:
42876751
Bibliographic data and abstract were imported from PubMed on 15 Oct 2026.

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