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

NCT06351111 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: IRB-24-240UG3NS131971
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

SCI - Spinal Cord Injury

Keywords

SCI - Spinal Cord Injury; VNS - Vagus Nerve Stimulation; TPT - Targeted Plasticity Therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (device safety)

  UL, LL, BC and SY - Review of adverse events reported throughout the trial will be used to inform the potential risks associated with the ReStore System

  Starting at session 1 on week 1, throughout the study up to last session 36 on week 15.

Secondary Outcomes (19)

• Jebsen-Taylor Hand Function (JTHF) Score

  At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.

• Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP)

  At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.

• Force & Range of motion

  At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.

• 6 Meter Walk Test (6MWT)

  At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.

• 10 Meter Walk Test (10MWT)

  At session 1 on week 1, session 36 on week 15, and as needed during intervening sessions from week 2 to 14.

Study Arms (4)

Upper limb (UL)

EXPERIMENTAL

Participants in this arm will receive up to 36 sessions of VNS paired with upper limb rehabilitative exercises

Device: Active VNS

Lower limb (LL)

EXPERIMENTAL

Participants in this arm will receive up to 36 sessions of VNS paired with lower limb rehabilitative exercises

Device: Active VNS

Bladder control (BC)

EXPERIMENTAL

Participants in this arm will receive up to 36 sessions of VNS paired with bladder control rehabilitative exercises

Device: Active VNS

Sensory (SY)

EXPERIMENTAL

Participants in this arm will receive up to 36 sessions of VNS paired with sensory rehabilitative exercises

Device: Active VNS

Interventions

Active VNS DEVICE

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

Bladder control (BC); Lower limb (LL); Sensory (SY); Upper limb (UL)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Completed phase 2 of the SCI EFS study (NCT04288245)
• Willing to comply with procedures for the entire duration of the study (study protocol compliance)
• Provision of signed and dated informed consent form
• Access to reliable communication and internet connections (for those intending to complete sessions at home)
• Has not had their VNS device explanted

You may not qualify if:

• Concurrent participation in another active interventional trial or participation in an active interventional trial within 7 days prior to enrollment
• Any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator
• Any condition which would preclude adequate evaluation of device's safety and performance in the judgment of the Investigator
• Concomitant clinically significant brain injuries
• Receiving any other therapy that would interfere with VNS
• Females of childbearing potential who are either pregnant, lactating, heterosexually active, or planning to become pregnant or heterosexually active during study participation; and who are not using, or will not agree to use medically acceptable birth control methods
• Psychiatric disorders, psychosocial, and/or cognitive impairment that would interfere with study participation, as assessed by medical evaluation
• Participants with a current or past: (i) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability; or (ii) non-medical situation or circumstance that, in the opinion of the principal investigator, study participation:
• May pose a significant or undue risk to the person;
• Make it unlikely the person will complete all the study requirements per protocol; or
• May adversely impact the integrity of the data or the validity of the study results
• Participants with active neoplastic disease.
• Participants with significant local circulatory problems, (e.g. thrombophlebitis and lymphedema, and clinically-significant hypotension or bradycardia).
• Participants with any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator.
• Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Texas Biomedical Device Center

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jane Wigginton

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

• Robert Rennaker

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

• Rita Hamilton

  Baylor Scott and White Institute for Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a non-randomized, open-label, adaptive, optional extension study model

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: April 8, 2024
• Study Start: August 29, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: November 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)