Interventional Enrolling by invitation
NCT04534556 on ClinicalTrials.gov
Wireless Nerve Stimulation Device To Enhance Recovery After Stroke
- Sponsor: Baylor Scott & White Research Institute
- Collaborators: The University of Texas at Dallas, University of Texas Southwestern Medical Center, National Institute of Neurological Disorders and Stroke (NINDS)
- Enrollment: 42 (Estimated)
- Study start: 2021-09-24 (Actual)
- Primary completion: 2027-01-01 (Estimated)
- Study completion: 2027-01-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Crossover
- InterventionModelDescription: Prospective, double blind, randomized placebo controlled, plus open-label extension
- Masking: Triple (Participant, Care Provider, Investigator)
- PrimaryPurpose: Device Feasibility
Brief 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.
Conditions
- Stroke
- Chronic Stroke
- Upper Extremity Paresis
- Ischemic Stroke
- Hemorrhagic Stroke
Intervention / Treatment
- Device: Active Vagus Nerve Stimulation
- Device: Placebo Vagus Nerve Stimulation
Primary Outcome 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
Countries
United States
Locations and Investigators
- Baylor Scott & White Institute for Rehabilitation, Dallas, United States
Study Officials
- 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