Wireless Nerve Stimulation Device To Enhance Recovery After Stroke

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

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.

Sponsors & Collaborators

• The University of Texas at Dallas

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Baylor Research Institute

  lead OTHER

Principal Investigators

• Michael Kilgard, PhD · The University of Texas at Dallas

• Robert Rennaker, PhD · The University of Texas at Dallas

• Seth Hays, PhD · The University of Texas at Dallas

• Jane Wigginton, MD · University of Texas Southwestern Medical Center

• Rita Hamilton, DO · Baylor Scott & White Institute for Rehabilitation

• Michael Foreman, MD, FACS · Baylor Health Care System

• Richard Naftalis, MD, FAANS, FACS · Baylor Health Care System

• Mark Powers, PhD · Baylor Health Care System

• Ann Marie Warren, PhD · Baylor Health Care System

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

22 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-01

Primary Completion

2027-02-25

Completion

2027-02-25

FDA Device

Yes

Countries

• United States

Study Locations