Nerve zapping + exercise shows promise for spinal injury recovery
NCT ID NCT06351111
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether stimulating the vagus nerve while doing rehabilitation exercises can help people with chronic spinal cord injury regain movement and sensation. Twenty participants who completed an earlier trial will receive active VNS paired with exercises targeting the upper limb, lower limb, bladder control, or sensory function. The main goal is to check safety, with secondary goals of measuring improvements in hand function and strength.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vagus nerve stimulation (VNS) device
- What this could lead to
- If successful, this could point toward a way to improve hand, leg, bladder, and sensory function in people with chronic spinal cord injury.
- What could go wrong
- This is a small, early-stage extension study with only 20 participants, so results may not apply to everyone. The device also carries risks like infection or nerve damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 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 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): 1. Pain that would impede study participation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor University Medical Center
Dallas, Texas, 75246, United States
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Texas Biomedical Device Center
Richardson, Texas, 75080, United States
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Other studies related to the condition(s) this trial covers.
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