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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
  • Device: Transcutaneous 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.

Recruiting Locations

Neurorecovery Research Center, TIRR MHH
Houston 4699066, Texas 4736286 77030
Contact:
Alyssa Miller, BS
7137977132
VNS.SCI@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Radha Korupolu, MD
713-797-5233
Radha.Korupolu@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.