Upper extremity motor outcomes during paired vagus nerve stimulation in chronic ischemic stroke: a retrospective single-health-system cohort study
- 1Atlantic Brain and Spine , , ,
- 2Atlantic Health , , ,
- 3Mobia Medical, Inc. , , ,
Abstract
Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
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BibTeX
@article{benitez2026upper,
title = {{Upper extremity motor outcomes during paired vagus nerve stimulation in chronic ischemic stroke: a retrospective single-health-system cohort study}},
author = {Ronald Benitez and Michelle Darling and Paige Zaorski and Quinn Galligan and Jack Maurer and Nicole McNamara and Shannon J. Doherty},
journal = {Frontiers in neurology},
year = {2026},
month = sep,
doi = {10.3389/fneur.2026.1872498},
url = {https://europepmc.org/article/PMC/PMC13661468},
note = {CC BY},
}
RIS
TY - JOUR
TI - Upper extremity motor outcomes during paired vagus nerve stimulation in chronic ischemic stroke: a retrospective single-health-system cohort study
AU - Ronald Benitez
AU - Michelle Darling
AU - Paige Zaorski
AU - Quinn Galligan
AU - Jack Maurer
AU - Nicole McNamara
AU - Shannon J. Doherty
PY - 2026
DA - 2026/09/30
JO - Frontiers in neurology
DO - 10.3389/fneur.2026.1872498
UR - https://europepmc.org/article/PMC/PMC13661468
AB - Background: 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. Methods: 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. Results: 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. Conclusions: 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.
SN - 1664-2295
ER -