Status:
RECRUITING
Safety and Feasibility of Paired Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) With Upper Limb Rehabilitation in Incomplete Spinal Cord Injury
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Mission Connect
Conditions:
Chronic Incomplete Cervical Spinal Cord Injury (SCI)
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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
Key Trial Info
Start Date :
August 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06543277
Start Date
August 15 2025
End Date
December 30 2027
Last Update
September 19 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Neurorecovery Research Center, TIRR MHH
Houston, Texas, United States, 77030
2
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030