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RecruitingNot ApplicableNCT06543277

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

Safety and Feasibility of Paired taVNS With Upper Limb Rehabilitation in Incomplete Spinal Cord Injury

Sponsor

The University of Texas Health Science Center, Houston

Enrollment

12 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Incomplete Cervical Spinal Cord Injury (SCI)

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria11

  • 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
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Interventions

DEVICETranscutaneous Auricular Vagus Nerve Stimulation (taVNS)

Participants will receive 18 goal-directed upper extremity rehabilitation therapy sessions with paired taVNS over six weeks, followed by a 90-day home exercise program.

Locations(2)

Neurorecovery Research Center, TIRR MHH

Houston, Texas, United States

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT06543277