Targeted Plasticity Therapy for Upper Limb Rehabilitation in Spinal Cord Injuries

Summary

Texas Biomedical Device Center at UT Dallas 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. Recovery is associated with neural plasticity in spared motor networks in the brain and spinal cord. Moreover, an early feasibility study and an independent, double-blind, placebo-controlled study in chronic stroke participants indicate that VNS is safe in participants with upper limb deficits, and yields a clinically-significant three-fold increase in neural connections during rehabilitation exercises. Given the track record of safety and potential for VNS to enhance recovery of upper limb motor function in spinal cord injured individuals, the purpose of this double blind randomized placebo controlled optional open-label extension study is to assess the safety of using a new device to deliver vagus nerve stimulation to reduce symptom severity in participants with SCI. Additionally, the study will assess the prospective benefit of the system and garner an initial estimate of efficacy for a subsequent trial. Participants may undergo additional sessions of training with VNS.

Conditions

• Spinal Cord Injuries
• Upper Extremity Paresis

Interventions

DEVICE

Active Vagus Nerve Stimulation

Stimulation of the vagus nerve that is paired with upper extremity rehabilitation. VNS stimulation as described in the current study consists of 0.5 s trains of 0.8 mA 100 µs biphasic pulses delivered 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

• Defense Advanced Research Projects Agency

  collaborator FED

• The University of Texas at Dallas

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Wings for Life

  collaborator OTHER

• 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

• Mark Powers, PhD · Baylor Health Care System

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

Study Design

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-15

Primary Completion

2026-09-30

Completion

2026-09-30

FDA Device

Yes

Countries

• United States

Study Locations