Wireless Nerve Stimulation Device To Enhance Recovery After Stroke

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 79
Healthy Volunteers: f
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⁃ 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

Locations
United States
Texas
Baylor Scott & White Institute for Rehabilitation
RECRUITING
Dallas
Contact Information
Primary
Alvaro Carrera
alvaro.carrera@bswhealth.org
469-831-5321
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 42
Treatments
Experimental: Immediate Start Vagus Nerve Stimulation group
The Immediate Start VNS group will receive rehabilitation and active stimulation for 18 in-office sessions over the course of approximately six weeks during Phase 1. For Phase 2, all subjects will be provided with the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately six weeks. Additionally, participants may be provided with a system of rehabilitative devices to utilize at home.
Placebo_comparator: Delayed Start Vagus Nerve Stimulation group
The Delayed Start VNS group will receive equivalent rehabilitation with placebo stimulation for 18 in-office sessions over the course of approximately six weeks during Phase 1. For Phase 2, all subjects will be provided with the option to participate in an open-label extension consisting of an additional 18 sessions of in-office rehabilitation with active VNS over the course of approximately six weeks. Additionally, participants may be provided with a system of rehabilitative devices to utilize at home.
Experimental: Follow-On Study Group
The Follow-On Study group will receive up to 112 rehabilitation sessions with active VNS over the course of approximately 36 weeks after completion of Phase II. Participants will be provided with a system of rehabilitative devices to utilize at home.
Related Therapeutic Areas
Sponsors
Collaborators: The University of Texas at Dallas, University of Texas Southwestern Medical Center, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: Baylor Research Institute

This content was sourced from clinicaltrials.gov

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