Clinical Trial

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

Study acronym: SCI-AFOS
Enrolling by Invitation
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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).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-04-01; most recent amendment 2026-06-02.
Status change: Withheld → Enrolling by Invitation 2024-08-13
Trial Details
NCT Number NCT06351111
Lead Sponsor The University of Texas at Dallas
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions SCI - Spinal Cord Injury
Enrollment 20 participants
Start Date 2024-08-29
Primary Completion 2027-05 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-06-04