RecruitingNot Applicable

Safety and Feasibility of Paired Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Upper Limb Rehabilitation in Incomplete Spinal Cord Injury

United States12 participantsStarted 2025-08-15

Plain-language summary

The purpose of this study is to evaluate the safety and feasibility of transcutaneous auricular Vagus Nerve Stimulation (taVNS) paired with upper-limb rehabilitation in adults with tetraplegia caused by cervical spinal cord injury.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above) * at least 12 months post-traumatic SCI but less than 10 years post-SCI * demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger sufficient to grip small objects such as marble) Exclusion Criteria: * non-traumatic SCI * recent ear trauma and skin lesions at the site of stimulation, such as sunburn, cuts, and open sores, * facial or ear pain, * allergic reaction to adhesives and electrodes, * any current or past history of cardiovascular disorders, * intracranial metal implants, pacemakers, * concomitant clinically significant brain injury, * receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry * If there is a plan for alteration in upper-extremity therapy or medication for muscle tone during the course of the study; * medical or mental instability; * pregnancy or plans to become pregnant during the study period

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety as assessed by number of subjects with change in systolic blood pressure

Timeframe: Immediately after completing in-clinic 18 sessions (6-8 weeks)

Safety as assessed by number of subjects with change in diastolic blood pressure

Timeframe: Immediately after completing in-clinic 18 sessions (6-8 weeks)

Safety as assessed by number of subjects with change in heart rate

Timeframe: Immediately after completing in-clinic 18 sessions (6-8 weeks)

Safety as assessed by number of subjects with change in respiratory rate

Timeframe: Immediately after completing in-clinic 18 sessions (6-8 weeks)

Safety as assessed by number of subjects with change in autonomic dysreflexia

Timeframe: Immediately after completing in-clinic 18 sessions (6-8 weeks)

Safety as assessed by number of subjects with worsening spasticity

Timeframe: Immediately after completing in-clinic 18 sessions (6-8 weeks)

Trial details

NCT IDNCT06543277

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Radha Korupolu, MD

713-797-5233 Radha.Korupolu@uth.tmc.edu

View on ClinicalTrials.gov More Chronic Incomplete Cervical Spinal Cord Injury (SCI) trials