Evidence map›Paper›PMID 41054846›Full record

Trial reportStroke2026

Closed-Loop Vagus Nerve Stimulation Delivered With a Miniaturized System Produces Lasting Recovery in Individuals With Chronic Stroke.

Seth A Hays, Emmanuel A Adehunoluwa, Joseph D Epperson, Kaitlyn M Malley, Amy L Porter, Holle L Gallaway, Chad Swank, Álvaro J Carrera, Christi Stevens, Jaime Gillespie and 11 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stroke, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04534556 (Wireless Nerve Stimulation Device To Enhance Recovery After Stroke), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04534556 naenrolling by invitationnot on this map

Wireless Nerve Stimulation Device To Enhance Recovery After Stroke

TypeinterventionalSponsorBaylor Research InstituteRan2021 to 2027Enrolled42ConditionsStroke, Chronic Stroke, Upper Extremity Paresis, Ischemic StrokeArmsActive Vagus Nerve Stimulation, Placebo Vagus Nerve Stimulation
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Seth A HaysDepartment of Bioengineering, Erik Jonsson School of Engineering and Computer Science (S.A.H., E.C.M.), University of Texas at Dallas, Richardson.ORCID 0000-0003-4225-241X
Emmanuel A AdehunoluwaTexas Biomedical Device Center (S.A.H., E.A.A., J.D.E., K.M.M., A.L.P., H.L.G., S.K., Z.S.B., E.C.M., N.B., R.L.R., M.P.K., J.G.W.), University of Texas at Dallas, Richardson.ORCID 0000-0002-5369-6959
Joseph D EppersonTexas Biomedical Device Center (S.A.H., E.A.A., J.D.E., K.M.M., A.L.P., H.L.G., S.K., Z.S.B., E.C.M., N.B., R.L.R., M.P.K., J.G.W.), University of Texas at Dallas, Richardson.ORCID 0000-0002-6430-8472
Kaitlyn M MalleyTexas Biomedical Device Center (S.A.H., E.A.A., J.D.E., K.M.M., A.L.P., H.L.G., S.K., Z.S.B., E.C.M., N.B., R.L.R., M.P.K., J.G.W.), University of Texas at Dallas, Richardson.
Amy L PorterTexas Biomedical Device Center (S.A.H., E.A.A., J.D.E., K.M.M., A.L.P., H.L.G., S.K., Z.S.B., E.C.M., N.B., R.L.R., M.P.K., J.G.W.), University of Texas at Dallas, Richardson.
Holle L GallawayTexas Biomedical Device Center (S.A.H., E.A.A., J.D.E., K.M.M., A.L.P., H.L.G., S.K., Z.S.B., E.C.M., N.B., R.L.R., M.P.K., J.G.W.), University of Texas at Dallas, Richardson.
Chad SwankBaylor Scott & White Research Institute, Dallas, TX (C. Swank, A.J.C.).
Álvaro J CarreraBaylor Scott & White Research Institute, Dallas, TX (C. Swank, A.J.C.).
Christi StevensBaylor Scott & White Institute for Rehabilitation, Dallas, TX (C. Swank, A.J.C., C. Stevens, J.G., D.A., R.G.H.).
Jaime GillespieBaylor Scott & White Institute for Rehabilitation, Dallas, TX (C. Swank, A.J.C., C. Stevens, J.G., D.A., R.G.H.).ORCID 0000-0002-8182-0160
Dannae ArnoldBaylor Scott & White Institute for Rehabilitation, Dallas, TX (C. Swank, A.J.C., C. Stevens, J.G., D.A., R.G.H.).ORCID 0000-0003-3334-9615
Saeid KianTexas Biomedical Device Center (S.A.H., E.A.A., J.D.E., K.M.M., A.L.P., H.L.G., S.K., Z.S.B., E.C.M., N.B., R.L.R., M.P.K., J.G.W.), University of Texas at Dallas, Richardson.
Zachary S BynumTexas Biomedical Device Center (S.A.H., E.A.A., J.D.E., K.M.M., A.L.P., H.L.G., S.K., Z.S.B., E.C.M., N.B., R.L.R., M.P.K., J.G.W.), University of Texas at Dallas, Richardson.ORCID 0000-0001-8620-2444
Eric C MeyersDepartment of Bioengineering, Erik Jonsson School of Engineering and Computer Science (S.A.H., E.C.M.), University of Texas at Dallas, Richardson.ORCID 0000-0002-2013-5450
Nate BlekerTexas Biomedical Device Center (S.A.H., E.A.A., J.D.E., K.M.M., A.L.P., H.L.G., S.K., Z.S.B., E.C.M., N.B., R.L.R., M.P.K., J.G.W.), University of Texas at Dallas, Richardson.ORCID 0000-0002-2251-3486
Richard C NaftalisDepartment of Neurosurgery, Baylor University of Medical Center, Dallas, TX (R.C.N.).
Michael L ForemanDivision of Acute Care Surgery, Baylor Scott & White Health, Dallas, TX (M.L.F.).ORCID 0000-0001-5790-0681
Rita G HamiltonBaylor Scott & White Institute for Rehabilitation, Dallas, TX (C. Swank, A.J.C., C. Stevens, J.G., D.A., R.G.H.).
Robert L RennakerTexas Biomedical Device Center (S.A.H., E.A.A., J.D.E., K.M.M., A.L.P., H.L.G., S.K., Z.S.B., E.C.M., N.B., R.L.R., M.P.K., J.G.W.), University of Texas at Dallas, Richardson.
Michael P KilgardTexas Biomedical Device Center (S.A.H., E.A.A., J.D.E., K.M.M., A.L.P., H.L.G., S.K., Z.S.B., E.C.M., N.B., R.L.R., M.P.K., J.G.W.), University of Texas at Dallas, Richardson.ORCID 0000-0002-6699-1818
Jane G WiggintonTexas Biomedical Device Center (S.A.H., E.A.A., J.D.E., K.M.M., A.L.P., H.L.G., S.K., Z.S.B., E.C.M., N.B., R.L.R., M.P.K., J.G.W.), University of Texas at Dallas, Richardson.ORCID 0009-0007-8547-1459

Funding

Wireless Nerve Stimulation Device To Enhance Recovery After StrokeUH3NS109497 · NINDS · UNIVERSITY OF TEXAS DALLAS · PI HAYS, SETH ALANSON, RENNAKER, ROBERT L · 2021 to 2023
$3.4M
FitMi VNS: The First Automated Home Therapy System for Exercise-Paired Vagus Nerve Stimulation After StrokeU44NS117306 · NINDS · FLINT REHABILITATION DEVICES · PI FRIEDMAN, NIZAN · 2021 to 2022
$1.5M
Wireless Nerve Stimulation Device To Enhance Recovery After StrokeUG3NS109497 · NINDS · UNIVERSITY OF TEXAS DALLAS · PI HAYS, SETH ALANSON, RENNAKER, ROBERT L · 2019 to 2020
$1.4M
NINDS NIH HHS U44 NS117306NINDS NIH HHS UG3 NS109497NINDS NIH HHS UH3 NS109497
6 · The paper itself

Abstract

backgroundThe combination of task-oriented training and vagus nerve stimulation has recently received US Food and Drug Administration approval to improve upper limb recovery in individuals with chronic stroke. Although conventional vagus nerve stimulation systems have a long track record of solid performance, they have been minimally redesigned since their entry onto the market in 1997 and are ripe for improvement. To leverage this opportunity, we developed a miniaturized system tailored specifically for closed-loop vagus nerve stimulation therapy (CLV). The system is ≈50-fold smaller, simplifies implantation, and interacts with sensors for closed-loop triggering during personalized rehabilitation sessions. Here, we performed a randomized, sham-controlled trial to evaluate the safety, feasibility, and initial effectiveness of this system.

methodsIn the primary study, conducted from September 2021 to January 2024 in Dallas, TX, 19 participants with ischemic stroke that occurred at least 1 year prior and residual upper limb deficits were implanted. Participants entered the double-blinded phase, during which they were randomized to receive 18 sessions of individualized, progressive rehabilitation with active CLV or sham stimulation followed by an additional 18 sessions of rehabilitation with active CLV, regardless of prior group assignment. After completion of this primary study, a subset of participants entered an exploratory extension during which they received up to 100 additional sessions of self-paced CLV at home.

resultsAnalysis of the primary outcome showed a nature and rate of adverse events similar to or below conventional vagus nerve stimulation devices. Heart rate and blood pressure were unaffected by CLV. Secondary functional outcomes demonstrated that, after CLV therapy in the randomized controlled trial phase, participants exhibited significant improvements in the upper extremity Fugl-Meyer score of 5.3±0.7 points over baseline (

conclusionsThese findings indicate that this miniaturized CLV system merits evaluation in a larger study. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04534556.

Indexed as

Recovery of FunctionStrokeStroke RehabilitationVagus Nerve StimulationAgedChronic DiseaseDouble-Blind MethodFemaleHumansMaleMiddle AgedMiniaturizationTreatment OutcomeUpper Extremityblood pressureheart rateischemic strokeupper extremityvagus nerve stimulation

Identifiers

PMID41054846
PMCPMC12614473

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.