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ENROLLING BY INVITATION
NCT06351111
NA

Vagus Nerve Stimulation (VNS) in Spinal Cord Injury (SCI) Adaptive Follow-On Study

Sponsor: The University of Texas at Dallas

View on ClinicalTrials.gov

Summary

This study is an open label extension of the SCI EFS clinical trial (NCT04288245) that developed an innovative strategy to enhance recovery of motor and sensory function after neurological injury. The objectives of this study are to provide continued safety assessment for the investigational ReStore system, and to gain further estimate of the effect of Vagus Nerve Stimulation (VNS) with rehabilitative exercises in four different tracks - upper limb (UL), lower limb (LL), bladder control (BC), and sensory (SY) for participants with chronic SCI (Spinal Cord Injury).

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-08-29

Completion Date

2028-05

Last Updated

2025-11-03

Healthy Volunteers

No

Interventions

DEVICE

Active VNS

Subjects will receive active VNS paired with track-specific rehabilitation exercises.

Locations (2)

Baylor University Medical Center

Dallas, Texas, United States

Texas Biomedical Device Center

Richardson, Texas, United States