Ear-based vagus nerve stimulation paired with arm rehabilitation for cervical spinal cord injury
Safety and Feasibility of Paired taVNS With Upper Limb Rehabilitation in Incomplete Spinal Cord Injury
This project tests whether ear-based vagus nerve stimulation combined with upper-limb rehabilitation is safe and helps improve hand and arm function in adults with chronic incomplete cervical spinal cord injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 2 sites (Houston, Texas and 1 other locations) |
| Trial ID | NCT06543277 on ClinicalTrials.gov |
What this trial studies
Adults with traumatic incomplete cervical spinal cord injury (AIS B-D), at least 12 months and under 10 years post-injury, who retain some residual hand movement will be enrolled. Participants receive transcutaneous auricular vagus nerve stimulation (taVNS) paired with guided upper-limb rehabilitation while clinicians record safety and feasibility outcomes. The protocol excludes non-traumatic SCI, people with cardiac disorders or implanted pacemakers, intracranial metal, significant brain injury, recent ear trauma, or medications that would interfere with VNS. Sessions take place at the Neurorecovery Research Center (TIRR Memorial Hermann) and UTHealth in Houston.
Who should consider this trial
Good fit: Ideal candidates are adults with traumatic incomplete cervical SCI (C8 or above, AIS B-D), between 12 months and less than 10 years after injury, who have some residual upper-limb movement such as a pinch grip.
Not a fit: Those unlikely to benefit include people with complete spinal cord injuries (AIS A), non-traumatic SCI, no detectable hand movement, or contraindications like cardiac disorders, pacemakers, intracranial metal, recent ear trauma, or medications that interfere with VNS.
Why it matters
Potential benefit: If successful, the approach could improve hand and arm function and enhance motor recovery for people with chronic incomplete cervical spinal cord injury.
How similar studies have performed: Vagus nerve stimulation paired with rehabilitation has shown promising motor recovery results in stroke studies, but transcutaneous auricular VNS for cervical SCI remains less established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas and 1 other locations
- Neurorecovery Research Center, TIRR MHH — Houston, Texas, United States (Recruiting)
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Radha Korupolu — The University of Texas Health Science Center, Houston
- Study coordinator: Radha Korupolu, MD
- Email: Radha.Korupolu@uth.tmc.edu
- Phone: 713-797-5233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.