RECRUITING

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

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Conditions

Chronic Incomplete Cervical Spinal Cord Injury (SCI)spinal cord injury (SCI)upper arm rehabilitation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety and Feasibility of Paired taVNS With Upper Limb Rehabilitation in Incomplete Spinal Cord Injury

Quick Facts

Study Start:2025-08-15
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06543277

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above)
  2. * at least 12 months post-traumatic SCI but less than 10 years post-SCI
  3. * 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)
  1. * non-traumatic SCI
  2. * recent ear trauma and skin lesions at the site of stimulation, such as sunburn, cuts, and open sores,
  3. * facial or ear pain,
  4. * allergic reaction to adhesives and electrodes,
  5. * any current or past history of cardiovascular disorders,
  6. * intracranial metal implants, pacemakers,
  7. * concomitant clinically significant brain injury,
  8. * receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry
  9. * If there is a plan for alteration in upper-extremity therapy or medication for muscle tone during the course of the study;
  10. * medical or mental instability;
  11. * pregnancy or plans to become pregnant during the study period

Contacts and Locations

Study Contact

Radha Korupolu, MD
CONTACT
713-797-5233
Radha.Korupolu@uth.tmc.edu
Shrasti Lohiya
CONTACT
(713) 797-7132
Shrasti.Lohiya@uth.tmc.edu

Principal Investigator

Radha Korupolu
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

Neurorecovery Research Center, TIRR MHH
Houston, Texas, 77030
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Radha Korupolu, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-15
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2025-08-15
Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

  • spinal cord injury (SCI)
  • upper arm rehabilitation

Additional Relevant MeSH Terms

  • Chronic Incomplete Cervical Spinal Cord Injury (SCI)