COMPLETED

Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury

Conditions

Cervical Spinal Cord Injury vagus nerve stimulation

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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 determine the safety and feasibility of pairing vagus nerve stimulation (VNS) with rehabilitation and to determine the efficacy of pairing VNS with rehabilitation.

Official Title

Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury: A Pilot Randomized Control Trial.

Quick Facts

Study Start:2023-06-15

Study Completion:2025-08-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05601661

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 Criteria	Exclusion Criteria
* a diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above) * at least 12 months post-traumatic SCI * demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger) * meet all clinical criteria for the surgical VNS implantation as determined by the PI, neurosurgeon, and anesthesiologist.	* non-traumatic SCI, injury * presence of ongoing dysphasia or aspiration difficulties * evidence of vagus pre-existing vocal cord paralysis as determined with laryngoscopy procedure * participants with prior left-sided anterior cervical surgery who exhibit too much of scar tissue at the surgery site which will be determined by neurosurgeon * concomitant clinically significant brain injury * history of prior injury to a vagus nerve * receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry * other comorbidities or complications that will hinder or contraindicate surgical procedure * medical or mental instability * pregnancy or plans to become pregnant during the study period.

Inclusion Criteria

Exclusion Criteria

* a diagnosis of traumatic incomplete (AIS B-D) cervical spinal cord injury (C8 and above)
* at least 12 months post-traumatic SCI
* demonstrate some residual movement in the upper limb (e.g., able to perform pinch movement with thumb and index finger)
* meet all clinical criteria for the surgical VNS implantation as determined by the PI, neurosurgeon, and anesthesiologist.

* non-traumatic SCI, injury
* presence of ongoing dysphasia or aspiration difficulties
* evidence of vagus pre-existing vocal cord paralysis as determined with laryngoscopy procedure
* participants with prior left-sided anterior cervical surgery who exhibit too much of scar tissue at the surgery site which will be determined by neurosurgeon
* concomitant clinically significant brain injury
* history of prior injury to a vagus nerve
* receiving medication that may significantly interfere with the actions of VNS on neurotransmitter systems at study entry
* other comorbidities or complications that will hinder or contraindicate surgical procedure
* medical or mental instability
* pregnancy or plans to become pregnant during the study period.

Contacts and Locations

Principal Investigator

Radha Korupolu

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

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 Date2023-06-15

Study Completion Date2025-08-16

Study Record Updates

Study Start Date2023-06-15

Study Completion Date2025-08-16

Terms related to this study

Keywords Provided by Researchers

vagus nerve stimulation

Additional Relevant MeSH Terms

Cervical Spinal Cord Injury