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Vagus Nerve Stimulation

Vagus Nerve Stimulation + Rehabilitation for Spinal Cord Injury

N/A
Recruiting
Led By Radha Korupolu
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study(about 132 days after enrollment)
Awards & highlights

Study Summary

This trial tests if pairing electrical stimulation of the vagus nerve with rehab can improve recovery after stroke.

Who is the study for?
This trial is for individuals at least 12 months post-traumatic cervical spinal cord injury (C8 and above), with some upper limb movement, like pinching. They must meet surgical criteria for VNS implantation. Excluded are those with non-traumatic SCI, vocal cord issues, significant brain injuries, prior vagus nerve damage, certain medications affecting neurotransmitters, other complicating conditions or surgeries, medical or mental instability, or pregnancy.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of pairing vagus nerve stimulation (VNS) with arm rehabilitation to improve upper extremity function in people with cervical spinal cord injury. Participants will receive either active VNS or a sham procedure alongside their rehabilitation exercises.See study design
What are the potential side effects?
Potential side effects may include discomfort from the VNS device itself and typical risks associated with any surgical implantation procedure. Specific side effects related to VNS can vary but might involve changes in voice tone or involuntary throat sensations.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study(about 132 days after enrollment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study(about 132 days after enrollment) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility as assessed by the number of participants that completed all the sessions
Feasibility as assessed by the number of participants that dropped out of the study
Safety as assessed by number of subjects with change in autonomic dysreflexia
+7 more
Secondary outcome measures
Change in Depression as assessed by the Patient Health Questionnaire (PHQ-8)
Pain
Change in capability of using arms and hands as assessed by the Capabilities of Upper Extremity Questionnaire (CUE-Q)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment groupExperimental Treatment2 Interventions
Participants in the treatment group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with paired VNS over six weeks. Followed by 90 days home exercise program.
Group II: Control GroupPlacebo Group2 Interventions
Participants in the control group will receive 18 goal-directed upper extremity rehabilitation therapy sessions with sham VNS over six weeks. Followed by 90 days home exercise program.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,952 Total Patients Enrolled
MicroTransponder Inc.Industry Sponsor
7 Previous Clinical Trials
1,336 Total Patients Enrolled
Radha KorupoluPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Active VNS (Vagus Nerve Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05601661 — N/A
Spinal Cord Injury Research Study Groups: Treatment group, Control Group
Spinal Cord Injury Clinical Trial 2023: Active VNS Highlights & Side Effects. Trial Name: NCT05601661 — N/A
Active VNS (Vagus Nerve Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05601661 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining openings available in this experiment for participants?

"As indicated on clinicaltrials.gov, this medical research is not taking on new participants at the moment; it was initially posted in December 1st 2022 and its last edit occurred on October 31st 2022. Despite being closed for enrollment, there are still 904 other studies that require volunteers presently."

Answered by AI

What objectives are being sought after through this experiment?

"According to the research sponsor, MicroTransponder Inc., the primary measure of safety will be assessed from a pre-treatment and post-treatment (approximately 6 weeks later) interval by recording changes in systolic blood pressure. Secondary outcomes including self care independence – as gauged through the Spinal cord injury Independence Measure - III subscore, pain intensity – via International SCI Pain Basic Data Subset v2 questionnaire, and hand function ability - using Toronto Rehab Institute Hand Function Test will also be evaluated."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury
Radha Korupolu 2023. "Safety and Feasibility of Paired Vagus Nerve Stimulation With Rehabilitation for Improving Upper Extremity Function in People With Cervical Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05601661.
~4 spots leftby Apr 2025
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