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Safety of taVNS with Upper Limb Rehab for Spinal Cord Injury

This study is looking at the safety and practicality of using Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) along with upper limb rehabilitation for people with chronic incomplete cervical spinal cord injury (SCI). You might be able to join if you have a traumatic incomplete SCI (C8 and above), are 1 to 10 years post-injury, and have some movement in your upper limbs, like being able to pinch with your thumb and index finger. The main goal is to see if taVNS is safe by checking changes in blood pressure and heart rate after 6-8 weeks of treatment. The study is currently recruiting 12 participants.

Study design
This is an interventional study planning to enroll 12 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will have 18 upper extremity rehabilitation therapy sessions with taVNS over six weeks, followed by a 90-day home exercise program.
Compensation
Not stated in the trial record.
Follow-up
Safety will be assessed immediately after completing the 18 in-clinic sessions (6-8 weeks).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06543277

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

Recruiting
NAAges 18+Interventional
The University of Texas Health Science Center, Houston
~12 participants
Updated 2025-09-19 on ClinicalTrials.gov
What's tested:Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety as assessed by number of subjects with change in systolic blood pressure
Measured over Immediately after completing in-clinic 18 sessions (6-8 weeks)
+10 more outcomes measured

Conditions

Chronic Incomplete Cervical Spinal Cord Injury (SCI)

Explore related trials

Spinal Cord Injury

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Radha Korupolu · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Radha Korupolu, MD
[email protected]
713-797-5233
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Safety as assessed by number of subjects with change in systolic blood pressureImmediately after completing in-clinic 18 sessions (6-8 weeks)
  • Safety as assessed by number of subjects with change in diastolic blood pressureImmediately after completing in-clinic 18 sessions (6-8 weeks)
  • Safety as assessed by number of subjects with change in heart rateImmediately after completing in-clinic 18 sessions (6-8 weeks)
  • Safety as assessed by number of subjects with change in respiratory rateImmediately after completing in-clinic 18 sessions (6-8 weeks)
  • Safety as assessed by number of subjects with change in autonomic dysreflexiaImmediately after completing in-clinic 18 sessions (6-8 weeks)
  • Safety as assessed by number of subjects with worsening spasticityImmediately after completing in-clinic 18 sessions (6-8 weeks)
  • Safety as assessed by number of subjects with change in pain at stimulation siteImmediately after completing in-clinic 18 sessions (6-8 weeks)
  • Safety as assessed by number of adverse events that occurred during the study periodpost therapy 30 days
  • Feasibility as assessed by the number of treatment sessions attended by each participant . The intervention is considered feasible if at least 80% adherence rate is achieved and no serious adverse events occurred.from baseline through completion of 18 sessions (about 6-8 weeks)

    80% adherence rate is defined as completing ≥ 16 out of 18 sessions

  • Feasibility as assessed by the participants' perceptions of the study proceduresfrom baseline through completion of 18 sessions (about 6-8 weeks)

    This includes implementation using the paired taVNS with rehabilitation. This is numerically rated from 'not difficult at all' at 0, and 'very difficult' at 10, higher score indicating worse outcome

  • Feasibility as assessed by the participants' perceptions of the usefulness of the interventionfrom baseline through completion of 18 sessions (about 6-8 weeks)

    This is numerically rated from ''not at all useful' at 0 and 'very useful' at 10 , higher score indicating better outcome