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NOT YET RECRUITING
NCT07689227
NA

Closed-Loop Vagus Nerve Stimulation (CLV) for Recovery of Gait

Sponsor: The University of Texas at Dallas

View on ClinicalTrials.gov

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).

Official title: Early Feasibility Study of the ReWire System for Closed-Loop Vagus Nerve Stimulation (CLV) Paired With Rehabilitation After Spinal Cord Injury (SCI)

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-09-30

Completion Date

2028-12

Last Updated

2026-07-08

Healthy Volunteers

No

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

Locations (4)

Spaulding Rehabilitation Hospital, Mass General Brigham

Boston, Massachusetts, United States

Urgent Surgery Associates, PA

Dallas, Texas, United States

Baylor University Medical Center (BUMC)

Dallas, Texas, United States

Texas Biomedical Device Center

Richardson, Texas, United States