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Wireless Nerve Stimulation for Stroke Recovery

This study is testing a wireless device that uses Vagus Nerve Stimulation (VNS) to help people recover movement after a stroke. VNS involves sending small electrical pulses to the vagus nerve, which runs from the brain to the abdomen. This stimulation is paired with rehabilitation exercises for the arm. Researchers believe this combination can help the brain reorganize itself and improve movement. You might be able to join if you are between 22 and 79 years old and had an ischemic or hemorrhagic stroke at least 12 months ago. The main goal is to see how safe the device is by tracking any side effects. The study is currently recruiting about 42 participants.

Study design
This interventional study plans to enroll 42 participants. During the first phase, some participants will receive active Vagus Nerve Stimulation (VNS) while others receive a placebo (inactive) VNS, both paired with rehabilitation. All participants will receive active VNS in the second phase.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for device safety from Week 1 through study follow-up, which is approximately two years after the implant date or final rehabilitation session (whichever comes second).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04534556

Wireless Nerve Stimulation Device To Enhance Recovery After Stroke

Enrolling by Invitation
NAAges 22–79InterventionalDevice feasibility
Baylor Research Institute
~42 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Active Vagus Nerve StimulationPlacebo Vagus Nerve Stimulation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events [Device Safety]
Measured over From Week 1 through study follow-up, approximately two years after the implant date or final session of rehabilitation (whichever comes second)

Conditions

Stroke
Chronic Stroke
Upper Extremity Paresis
Ischemic Stroke
Hemorrhagic Stroke

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Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Michael Kilgard, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas at Dallas
  • Robert Rennaker, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas at Dallas
  • Seth Hays, PhD · STUDY_DIRECTOR · The University of Texas at Dallas
  • Jane Wigginton, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
  • Rita Hamilton, DO · PRINCIPAL_INVESTIGATOR · Baylor Scott & White Institute for Rehabilitation
  • Michael Foreman, MD, FACS · STUDY_DIRECTOR · Baylor Health Care System
  • Richard Naftalis, MD, FAANS, FACS · STUDY_DIRECTOR · Baylor Health Care System
  • Mark Powers, PhD · STUDY_DIRECTOR · Baylor Health Care System
  • Ann Marie Warren, PhD · STUDY_DIRECTOR · Baylor Health Care System

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Adult, aged 22-79
Ischemic or hemorrhagic stroke that occurred ≥ 12 months prior to enrollment
UEFM score of 20 to 50
Modified Rankin Score of 2, 3, or 4
Right vocal cord has normal movement when assessed by laryngoscopy
Women of reproductive potential must use contraceptive protection
Meets all clinical criteria for the surgical VNS implantation as determined by the PI, surgeon, and anesthesiologist

Exclusion

Deficits in language or attention that interfere with study participation
Severe spasticity (Modified Ashworth ≥ 3)
Medical or mental instability that would likely interfere with study protocol
Receiving any therapy (medication or otherwise) that would interfere with VNS, such as drugs that perturb neurotransmitter action (anticholinergics, adrenergic blockers, etc.)
Presence of any other implanted electrical stimulation device
Prior injury to vagus nerve
Lactating, pregnant, or plan to become pregnant
Participation in another interventional clinical trial
Clinical complications that hinder or contraindicate the surgical procedure
Abusive use of alcohol and/or illegal substances use
Participants with sickle cell, lupus, clotting disorders or active neoplastic disease.
Participants with any any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator.
Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
Recent history of syncope
Recent history of dysphagia
Current or anticipated requirement for diathermy
Uncontrolled hypertension
Diagnosed with Cerebral amyloid angiopathy

What this trial measures

  • Incidence of Adverse Events [Device Safety]From Week 1 through study follow-up, approximately two years after the implant date or final session of rehabilitation (whichever comes second)

    Review of adverse events reported throughout the trial will be used to inform the potential risks associated with the ReStore system and provide a better understanding of risk/benefit analysis