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

The University of Texas System (UT)

Status

Enrolling

Conditions

Chronic Incomplete Cervical Spinal Cord Injury (SCI)

Treatments

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Study type

Interventional

Funder types

Other

Identifiers

NCT06543277

HSC-MS-24-0346

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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