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Recruiting NCT06543277

NCT06543277 Safety and Feasibility of Paired Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Upper Limb Rehabilitation in Incomplete Spinal Cord Injury

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Clinical Trial Summary
NCT ID NCT06543277
Status Recruiting
Phase —
Sponsor The University of Texas Health Science Center, Houston
Condition Chronic Incomplete Cervical Spinal Cord Injury (SCI)
Study Type INTERVENTIONAL
Enrollment 12 participants
Start Date 2025-08-15
Primary Completion 2027-06-30

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 12 participants in total. It began in 2025-08-15 with a primary completion date of 2027-06-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

Eligibility Criteria

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

Contact & Investigator

Central Contact

Radha Korupolu, MD

✉ Radha.Korupolu@uth.tmc.edu

📞 713-797-5233

Principal Investigator

Radha Korupolu

PRINCIPAL INVESTIGATOR

The University of Texas Health Science Center, Houston

Frequently Asked Questions

Who can join the NCT06543277 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Incomplete Cervical Spinal Cord Injury (SCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06543277 currently recruiting?

Yes, NCT06543277 is actively recruiting participants. Contact the research team at Radha.Korupolu@uth.tmc.edu for enrollment information.

Where is the NCT06543277 trial being conducted?

This trial is being conducted at Houston, United States, Houston, United States.

Who is sponsoring the NCT06543277 clinical trial?

NCT06543277 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Radha Korupolu at The University of Texas Health Science Center, Houston. The trial plans to enroll 12 participants.

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