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

NCT ID: NCT06543277

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-15

Study Completion Date

2027-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Incomplete Cervical Spinal Cord Injury (SCI)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Group Type EXPERIMENTAL

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mission Connect

UNKNOWN

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Radha Korupolu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Radha Korupolu

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Neurorecovery Research Center, TIRR MHH

Houston, Texas, United States

Site Status RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Radha Korupolu, MD

Role: CONTACT

713-797-5233

Shrasti Lohiya

Role: CONTACT

(713) 797-7132

Facility Contacts

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Alyssa Miller, BS

Role: primary

7137977132

Radha Korupolu, MD

Role: primary

713-797-5233

Shrasti Lohiya

Role: backup

(713) 797-7132

Other Identifiers

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HSC-MS-24-0346

Identifier Type: -

Identifier Source: org_study_id

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