Closed-Loop Vagus Nerve Stimulation (CLV) for Recovery of Gait After Spinal Cord Injury (SCI)

Summary

The purpose of this study is to evaluate the safety, feasibility, and preliminary effectiveness of the ReWire system, which delivers vagus nerve stimulation (VNS) paired with lower limb rehabilitation to improve gait in individuals with mobility impairments resulting from chronic, incomplete spinal cord injury (SCI).

Conditions

• Spinal Cord Injury (SCI)
• Gait
• Reduced Physical Activity
• Lower Limb Functions
• Walking Impairment
• Mobility Impairment
• Functional Mobility

Interventions

DEVICE

CLV

The participants in this group will be implanted with the ReWire system and receive CLV in the double-blind phase

DEVICE

Sham

The participants in this group will be implanted with the ReWire system and receive Sham in the double-blind phase

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• The University of Texas at Dallas

  lead OTHER

Principal Investigators

• Jane Wigginton, MD · The University of Texas at Dallas

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

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

• Rita Hamilton, DO · Baylor University Medical Center (BUMC)

• Chad Swank, PhD · Spaulding Rehabilitation Hospital, Mass General Brigham

• Michael Foreman, MD · Urgent Surgery Associates, PA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Device

Yes

Countries

• United States

Study Locations