AzTrials
AzTrials

SCI - Spinal Cord InjurySCI-AFOSNCT06351111

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

A study testing Active VNS in people with SCI - Spinal Cord Injury, run by The University of Texas at Dallas at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
SCI - Spinal Cord Injury
What is being tested?
Active VNS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
29 Aug 2024to May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

General 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

General 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
  4. Individuals who have a change in medical condition or health status such that they would meet the exclusion criteria of the EFS
  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:
  10. May pose a significant or undue risk to the person;
  11. Make it unlikely the person will complete all the study requirements per protocol; or
  12. May adversely impact the integrity of the data or the validity of the study results
  13. Participants with active neoplastic disease.
  14. Participants with significant local circulatory problems, (e.g. thrombophlebitis and lymphedema, and clinically-significant hypotension or bradycardia).
  15. 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.
  16. Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
  17. 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.
  18. A recent history of syncope
  19. A recent history of dysphagia
  20. Currently require, or are likely to require diathermy
  21. Significant respiratory issues that would interfere with participation
  22. Non-English speaking
  23. Patients who are acutely suicidal and/or have been admitted for a suicide attempt
  24. As determined by the principal investigator, is under current incarceration or legal detention

Track Specific Inclusion Criteria:

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 Track Specific Exclusion Criteria: 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):
  6. Pain that would impede study participation

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites
  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Texas Biomedical Device Center

    Richardson, Texas, 75080

Other trials in United States

About this study

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).

Read the 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.

Being tested
Active VNS
Keywords
SCI - Spinal Cord Injury, VNS - Vagus Nerve Stimulation, TPT - Targeted Plasticity Therapy
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active VNSDevice

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

Study groups in NCT06351111
Study groupRoleWhat they receive
Upper limb (UL)ExperimentalParticipants in this arm will receive up to 36 sessions of VNS paired with upper limb rehabilitative exercises
Receives: Device: Active VNS
Lower limb (LL)ExperimentalParticipants in this arm will receive up to 36 sessions of VNS paired with lower limb rehabilitative exercises
Receives: Device: Active VNS
Bladder control (BC)ExperimentalParticipants in this arm will receive up to 36 sessions of VNS paired with bladder control rehabilitative exercises
Receives: Device: Active VNS
Sensory (SY)ExperimentalParticipants in this arm will receive up to 36 sessions of VNS paired with sensory rehabilitative exercises
Receives: Device: Active VNS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (19)
  1. Jebsen-Taylor Hand Function (JTHF) Score

    UL only - Determine whether VNS therapy improves Jebsen-Taylor Hand Function (JTHF) score compared to baseline. This measure is not a scale. Each item is timed from 0 to 120 seconds. Lower/faster values are better.

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

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

    UL only - Determine whether VNS therapy improves the GRASSP score compared to baseline. This scale is from 0 to 116 points. Higher scores are better.

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

  3. Force & Range of motion

    UL only - Determine whether VNS therapy improves force and range of motion in the hand and wrist compared to baseline.

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

  4. 6 Meter Walk Test (6MWT)

    LL only - Determine whether VNS therapy improves six-minute walking test (6MWT) score compared to baseline. This measure is not a scale. Higher distance covered is better.

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

  5. 10 Meter Walk Test (10MWT)

    LL only - Determine whether VNS therapy improves 10-Meter Walk Test (10-MWT) score compared to baseline. This measure is not a scale. Lower time to complete is better.

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

  6. Walking Index for Spinal Cord Injury II (WISCI II)

    LL only - Determine whether VNS therapy improves Walking Index for Spinal Cord Injury II (WISCI II) score compared to baseline. This scale is from 0-20. Higher scores are better.

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

  7. Berg's Balance Scale (BBG)

    LL only - Determine whether VNS therapy improves Berg's Balance Scale (BBG) score compared to baseline. This scale is from 0 to 56. Higher scores are better.

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

  8. Timed Up-and Go (TUG)Test

    LL only - Determine whether VNS therapy improves Timed Up-and Go (TUG)Test score compared to baseline. This measure is not a scale. Lower time to complete is better.

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

  9. Lower Extremity Motor Score (LEMS)

    LL only - Determine whether VNS therapy improves Lower Extremity Motor Score (LEMS) compared to baseline. This scale is from 0 to 50. Higher scores are better.

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

  10. Voiding efficiency

    BC only - Estimate the shift in voiding efficiency through bladder ultrasonography assessment following active VNS

    Measured: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.

  11. Bladder volume capacity

    BC only - Estimate the shift in bladder volume capacity during bladder ultrasonography assessment following active VNS

    Measured: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.

  12. Postvoid residual volume (PVR)

    BC only - Estimate the shift in PVR during bladder ultrasonography assessment following active VNS

    Measured: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.

  13. Neurogenic Bladder Symptom Score (NBSS) questionnaire

    BC only - Estimate the shift in NBSS score following active VNS. This scale is from 0 to 78. Lower scores are better.

    Measured: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.

  14. Urinary Distress Inventory (UDI-6), short form questionnaire

    BC only - Estimate the shift in the UDI-6 questionnaire score following active VNS. This scale is from 0 to 18. Lower scores are better.

    Measured: At session 1 on week 1, session 36 on week 13, and as needed during intervening sessions on week 2 to 13.

  15. Two - Point Discrimination

    SY only - Determine whether VNS therapy improves Two-Point Discrimination (2PD) score compared to baseline. This measure is not a scale but the ability to feel two separate points of touch on the skin instead of just one. It's a sensory test used in neurological exams to assess the density and health of nerve innervation in a specific area of the body. The test involves determining the smallest distance between two points that a person can still perceive as two separate stimuli.

    Measured: At session 1 on week 1, on week 8, week 12 and as needed during intervening sessions from week 2 to 7.

  16. Tactile Discrimination Test (TDT)

    SY only- Determine whether VNS therapy improves Tactile Discrimination Test (TDT) score compared to baseline. This scale is from 0 to 25 points. Higher scores are better.

    Measured: At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.

  17. Semmes-Weinstein Monofilaments (SWM)

    SY only - Determine whether VNS therapy improves Semmes-Weinstein Monofilaments (SWM) test score compared to baseline. This measure is not a scale but a test to assess a person's light touch sensation using a set of filaments of different thickness to identify loss of protective sensation in areas like feet or hands. The level of the filament required to elicit a response provides a measurement of the patient's sensory threshold. Thinner filament indicates better sensory function.

    Measured: At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.

  18. US-Nottingham Sensory Assessment (US-NSA)

    SY only - Determine whether VNS therapy improves US-Nottingham Sensory Assessment (US-NSA) score compared to baseline. This assessment is a scale ranging from 0 to 92 for the upper extremity, and 0 to 172 for the combined upper and lower extremities. Higher scores indicate better sensory function.

    Measured: At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.

  19. International SCI Pain Basic Data

    SY only- Determine whether VNS therapy can reduce pain severity and improve patient-reported outcomes of the International SCI Pain Basic Data Set, compared to baseline measures. This measure uses a numeric rating scale from 0 to 10, where 0 indicates no pain. Lower scores indicate lower pain intensity.

    Measured: At session 1 on week 1, on week 8, week 12, and as needed during intervening sessions from week 2 to 7.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2024
  2. Study start29 Aug 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
This is a non-randomized, open-label, adaptive, optional extension study model
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06351111
Sponsor's protocol ID
IRB-24-240
Other IDs
UG3NS131971
Acronym
SCI-AFOS
Status last verified
Jun 2026
First submitted
5 Mar 2024
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active VNS in people with SCI - Spinal Cord Injury, run by The University of Texas at Dallas at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (device safety) (time frame: Starting at session 1 on week 1, throughout the study up to last session 36 on week 15.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in