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RECRUITING

NCT04534556

Wireless Nerve Stimulation Device To Enhance Recovery After Stroke

Sponsor: Baylor Research Institute

View on ClinicalTrials.gov

Summary

Texas Biomedical Device Center (TxBDC) has developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury termed targeted plasticity therapy (TPT). This technique uses brief pulses of vagus nerve stimulation to engage pro-plasticity neuromodulatory circuits during rehabilitation exercises. Preclinical findings demonstrate that VNS paired with rehabilitative training enhances recovery in multiple models of neurological injury, including stroke, spinal cord injury, intracerebral hemorrhage, and traumatic brain injury. Recovery is associated with neural plasticity in spared motor networks in the brain and spinal cord. Moreover, two initial studies and a recently completed Phase 3 clinical trial using a commercially available device demonstrates that paired VNS with rehabilitation is safe and improves motor recovery after stroke. The purpose of this study is to extend these findings and evaluate whether VNS delivered with the new device paired with rehabilitation represents a safe and feasible strategy to improve recovery of motor and sensory function in participants with stroke.

Key Details

Gender

All

Age Range

22 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-09-01

Completion Date

2027-02-25

Last Updated

2026-03-23

Healthy Volunteers

Conditions

Stroke Chronic Stroke Upper Extremity Paresis Ischemic Stroke Hemorrhagic Stroke

Interventions

DEVICE

Active Vagus Nerve Stimulation

Stimulation of the vagus nerve that is paired with upper limb rehabilitation. VNS stimulation as described in the current study consists of 0.5 second trains of 0.8 mA; 100 µsec biphasic pulses at 30 Hz. Stimulation trains are delivered only during rehabilitation.

DEVICE

Placebo Vagus Nerve Stimulation

During Phase 1 of the study, the placebo group will receive a minimal amount of stimulation that fails to sufficiently activate the nerve, unknown to the participant and therapists. All participants will receive active stimulation during the Phase 2 open-label portion of the study.

Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * 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 Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * 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

Locations (1)

Baylor Scott & White Institute for Rehabilitation

Dallas, Texas, United States