RECRUITING

Wireless Nerve Stimulation Device To Enhance Recovery After Stroke

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Wireless Nerve Stimulation Device To Enhance Recovery After Stroke

Quick Facts

Study Start:2021-09-01
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04534556

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Adult, aged 22-79
  4. * Ischemic or hemorrhagic stroke that occurred ≥ 12 months prior to enrollment
  5. * UEFM score of 20 to 50
  6. * Modified Rankin Score of 2, 3, or 4
  7. * Right vocal cord has normal movement when assessed by laryngoscopy
  8. * Women of reproductive potential must use contraceptive protection
  9. * Meets all clinical criteria for the surgical VNS implantation as determined by the PI, surgeon, and anesthesiologist
  1. * Deficits in language or attention that interfere with study participation
  2. * Severe spasticity (Modified Ashworth ≥ 3)
  3. * Medical or mental instability that would likely interfere with study protocol
  4. * Receiving any therapy (medication or otherwise) that would interfere with VNS, such as drugs that perturb neurotransmitter action (anticholinergics, adrenergic blockers, etc.)
  5. * Presence of any other implanted electrical stimulation device
  6. * Prior injury to vagus nerve
  7. * Lactating, pregnant, or plan to become pregnant
  8. * Participation in another interventional clinical trial
  9. * Clinical complications that hinder or contraindicate the surgical procedure
  10. * Abusive use of alcohol and/or illegal substances use
  11. * Participants with sickle cell, lupus, clotting disorders or active neoplastic disease.
  12. * 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.
  13. * Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
  14. * Recent history of syncope
  15. * Recent history of dysphagia
  16. * Current or anticipated requirement for diathermy
  17. * Uncontrolled hypertension
  18. * Diagnosed with Cerebral amyloid angiopathy

Contacts and Locations

Study Contact

Alvaro Carrera
CONTACT
469-831-5321
alvaro.carrera@bswhealth.org

Principal Investigator

Michael Kilgard, PhD
PRINCIPAL_INVESTIGATOR
University of Texas at Dallas
Robert Rennaker, PhD
PRINCIPAL_INVESTIGATOR
University of Texas at Dallas
Seth Hays, PhD
STUDY_DIRECTOR
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

Study Locations (Sites)

Baylor Scott & White Institute for Rehabilitation
Dallas, Texas, 75246
United States

Collaborators and Investigators

Sponsor: Baylor Research Institute

  • Michael Kilgard, PhD, PRINCIPAL_INVESTIGATOR, University of Texas at Dallas
  • Robert Rennaker, PhD, PRINCIPAL_INVESTIGATOR, University of Texas at Dallas
  • Seth Hays, PhD, STUDY_DIRECTOR, 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-01
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2021-09-01
Study Completion Date2025-01-31

Terms related to this study

Keywords Provided by Researchers

  • Vagus Nerve Stimulation (VNS)
  • Rehabilitation
  • Targeted Plasticity Therapy

Additional Relevant MeSH Terms

  • Stroke
  • Chronic Stroke
  • Upper Extremity Paresis
  • Ischemic Stroke
  • Hemorrhagic Stroke