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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06543277
Status
Recruiting
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Conditions

  • Chronic Incomplete Cervical Spinal Cord Injury (SCI)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 15, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

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) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Neurorecovery Research Center, TIRR MHHHoustonTexas77030
Alyssa Miller, BS
[email protected]
7137977132
The University of Texas Health Science Center at HoustonHoustonTexas77030
Radha Korupolu, MD
[email protected]
713-797-5233
Shrasti Lohiya
[email protected]
(713) 797-7132

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By research site
Neurorecovery Research Center, TIRR MHH· Houston, TXThe University of Texas Health Science Center at Houston· Houston, TX