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

NCT ID: NCT06351111

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-29
• Study Completion Date: 2028-05-31

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).

Detailed Description

A prospective, multi-center, non-randomized, open label extension of the SCI EFS trial (NCT04288245) participants implanted with the investigational ReStore Device for VNS Therapy. Following the completion of Phase 2 of the SCI EFS study, participants can enroll to one of the four tracks. Under each track, participants will undergo up to 36 sessions of rehabilitative exercises self-paced by participants with targeted completion of 3 sessions per week. Evaluations will be administered at the beginning and end of each track (additional progress checks may be conducted, as required by the staff) to monitor participant progress. Upon completion of a track, participants can choose to re-enroll in the same or a different track. Adverse events will be documented and assessed throughout the trial.

Conditions

SCI - Spinal Cord Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Upper limb (UL)

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

Group Type: EXPERIMENTAL

Active VNS

Intervention Type: DEVICE

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

Lower limb (LL)

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

Group Type: EXPERIMENTAL

Active VNS

Intervention Type: DEVICE

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

Bladder control (BC)

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

Group Type: EXPERIMENTAL

Active VNS

Intervention Type: DEVICE

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

Sensory (SY)

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

Group Type: EXPERIMENTAL

Active VNS

Intervention Type: DEVICE

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

Interventions

Active VNS

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Completed phase 2 of the SCI EFS study (NCT04288245)

2. Willing to comply with procedures for the entire duration of the study (study protocol compliance)

3. Provision of signed and dated informed consent form

4. Access to reliable communication and internet connections (for those intending to complete sessions at home)

5. Has not had their VNS device explanted

Upper Limb (UL):

1)None

Lower Limb (LL):

1)Ambulatory with gait impairment

Bladder Control (BC):

1)Issues with urinary function arising from SCI, with partial voluntary initiation of voiding 2)Intermittent catheterization for bladder management

Sensory (SY):

1)Impairment in sensory function, based on the baseline assessments below:

1. US-NSA score <92 points

2. Two-point discrimination fingertip score >5mm

3. Two-point discrimination palm score >15mm

4. Tactile Discrimination Test score <16points

5. Semmes-Weinstein Monofilaments score >3.61g

Exclusion Criteria

1. Concurrent participation in another active interventional trial or participation in an active interventional trial within 7 days prior to enrollment

2. Any medical condition or other circumstances that might interfere with their ability to return for follow-up visits in the judgment of the Investigator

3. Any condition which would preclude adequate evaluation of device's safety and performance in the judgment of the Investigator

5. Concomitant clinically significant brain injuries

6. Receiving any other therapy that would interfere with VNS

7. 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

8. Psychiatric disorders, psychosocial, and/or cognitive impairment that would interfere with study participation, as assessed by medical evaluation

9. 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:

1. May pose a significant or undue risk to the person;

2. Make it unlikely the person will complete all the study requirements per protocol; or

3. May adversely impact the integrity of the data or the validity of the study results

10. Participants with active neoplastic disease.

11. Participants with significant local circulatory problems, (e.g. thrombophlebitis and lymphedema, and clinically-significant hypotension or bradycardia).

12. 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.

13. Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.

14. Aphasia and other cognitive deficits may be present but participants will be excluded if are unable to understand the potential risks and benefits of the study or personally provide informed consent.

15. A recent history of syncope

16. A recent history of dysphagia

17. Currently require, or are likely to require diathermy

18. Significant respiratory issues that would interfere with participation

19. Non-English speaking

20. Patients who are acutely suicidal and/or have been admitted for a suicide attempt

21. As determined by the principal investigator, is under current incarceration or legal detention

Upper Limb (UL):

1)None

Lower Limb (LL):

1)None

Bladder Control (BC):

1)Indwelling catheter use 2)Participants with a history of severe or recurrent autonomic dysreflexia 3)Technical limitations that would preclude bladder ultrasonography assessments 4)Medical history that would preclude adequate evaluation of urologic outcomes

Sensory (SY):

1. Pain that would impede study participation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

The University of Texas at Dallas

OTHER

Sponsor Role: lead

Responsible Party

Dr. Seth Hays

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jane Wigginton

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Dallas

Robert Rennaker

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Dallas

Rita Hamilton

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott and White Institute for Rehabilitation

Locations

Baylor University Medical Center

Dallas, Texas, United States

Texas Biomedical Device Center

Richardson, Texas, United States

Countries

United States

Other Identifiers

UG3NS131971

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-24-240

Identifier Type: -

Identifier Source: org_study_id