Recruiting

taVNS & Rehabilitation

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06543277

Conditions

Chronic Incomplete Cervical Spinal Cord Injury (SCI)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Study Details

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 by cervical spinal cord injury.

Conditions

Chronic Incomplete Cervical Spinal Cord Injury (SCI)

Study ID

NCT06543277

Start date

Aug 15, 2025

Status verified date

Sep, 2025

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Interventions

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.

Primary outcome measure

  • Safety as assessed by number of subjects with change in systolic blood pressure [ Time Frame: Immediately after completing in-clinic 18 sessions (6-8 weeks) ]
  • Safety as assessed by number of subjects with change in diastolic blood pressure [ Time Frame: Immediately after completing in-clinic 18 sessions (6-8 weeks) ]
  • Safety as assessed by number of subjects with change in heart rate [ Time Frame: Immediately after completing in-clinic 18 sessions (6-8 weeks) ]
  • Safety as assessed by number of subjects with change in respiratory rate [ Time Frame: Immediately after completing in-clinic 18 sessions (6-8 weeks) ]
  • Safety as assessed by number of subjects with change in autonomic dysreflexia [ Time Frame: Immediately after completing in-clinic 18 sessions (6-8 weeks) ]
  • Safety as assessed by number of subjects with worsening spasticity [ Time Frame: Immediately after completing in-clinic 18 sessions (6-8 weeks) ]
  • Safety as assessed by number of subjects with change in pain at stimulation site [ Time Frame: Immediately after completing in-clinic 18 sessions (6-8 weeks) ]
  • Safety as assessed by number of adverse events that occurred during the study period [ Time Frame: post therapy 30 days ]
  • Feasibility as assessed by the number of treatment sessions attended by each participant . The intervention is considered feasible if at least 80% adherence rate is achieved and no serious adverse events occurred. [ Time Frame: from baseline through completion of 18 sessions (about 6-8 weeks) ]
  • Feasibility as assessed by the participants' perceptions of the study procedures [ Time Frame: from baseline through completion of 18 sessions (about 6-8 weeks) ]
  • Feasibility as assessed by the participants' perceptions of the usefulness of the intervention [ Time Frame: from baseline through completion of 18 sessions (about 6-8 weeks) ]

Central Contacts and Locations

Central contacts

Radha Korupolu, MD

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

Shrasti Lohiya

(713) 797-7132Shrasti.Lohiya@uth.tmc.edu

Locations

Neurorecovery Research Center, TIRR MHH

Recruiting

Houston, Texas, United States, 77030

Contacts

Alyssa Miller, BS

7137977132VNS.SCI@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Keywords

  • spinal cord injury (SCI)
  • upper arm rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-09-19.