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Pilot Testing of Vagus Nerve Stimulation for Early Spinal Cord Injury Recovery

Phase 2Not Yet RecruitingNCT07562113
University of Alabama at Birmingham50 enrolled

Overview

This study looks at a treatment called transcutaneous auricular vagus nerve stimulation, or taVNS. taVNS uses a small device worn on the ear to gently stimulate a nerve. Researchers want to find out if this treatment is safe and well-tolerated for people who recently had a spinal cord injury (SCI). This study will also help researchers learn whether taVNS can be safely added to standard mobility therapy, and whether it might help improve mobility. This study has two main goals: 1. To find out whether taVNS is safe and comfortable for people with a recent spinal cord injury. 2. To get information on whether taVNS may help improve mobility when compared to people who completed rehabilitation before this study started. This study has two parts. In the first part, participants will wear the taVNS device once for a short period of time. During this part investigators will measure how participant's heart rate and blood pressure may change before, during, and after the stimulation. Investigators will also ask about how the stimulation made participants feel. In the second part, participants will wear the taVNS device for a short time right before a mobility therapy session. During this part investigators will measure how participants heart rate and blood pressure may change before, during, and after the stimulation and during and after the walking therapy. Investigators will also ask about how the stimulation made participants feel.

Study Type

INTERVENTIONAL

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Enrollment

50

Conditions

Spinal Cord Injuries (Complete and Incomplete)

Interventions

Transauricular vagus nerve stimulationDEVICE

bilateral transauricular vagal nerve stimulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years
Medical Language ↔ Plain English
Inclusion Criteria: * Phase 1 Age 18 years older SCI (traumatic or non traumatic) undergoing initial inpatient rehabilitation for the SCI Any AIS severity level (A, B, C, D) * Phase 2 Completed phase I Participant willing to complete phase II Study physician approves participation in phase II Receives intensive gait training as a part of the care plan Exclusion Criteria: * Phase 1 Age \>89 years Pregnant Implanted medical device (e.g. pacemaker, cochlear implant) epilepsy Parkinson's Disease Multiple Sclerosis cerebral shunts documented arrhythmia Ear skin irritation or damage at the electrode contact location intracranial metal implants * Phase 2 no exclusion criteria for those who meet inclusion criteria

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Phase 1 Hypotension Symptoms Immediately before taVNS is applied

Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible

Time frame: Immediately before Phase 1 taVNS application

Phase 1 Hypotension Symptoms during taVNS spplication

Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible

Time frame: During application of Phase 1 taVNS

Phase 1 Hypotension Symptoms Immediately after taVNS is stopped

Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible

Time frame: Immediately after Phase 1 taVNS is stopped

Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped

Six questions about hypotensive symptoms rated on a 0 to 10 scale, with 0 as none and 10 worst possible

Time frame: 5 minutes after Phase 1 taVNS is stopped

Phase 1 taVNS Tolerability survey

10 question survey addressing perceived sensation, tolerability, side effects, and open text response

Time frame: Within 48 hours of competing Phase 1 taVNS

Phase 2 taVNS Tolerability survey

10 question survey addressing perceived sensation, tolerability, side effects, and open text response

Time frame: Within 48 hours of completing Phase 2 taVNS

Secondary Outcomes

Phase 1 Blood Pressure Immediately before taVNS is applied

Systolic and Diastolic Blood Pressure (mmHg)

Time frame: Immediately before taVNS Phase 1 application is applied

Phase 1 Blood Pressure during taVNS application

Systolic and Diastolic Blood Pressure (mmHg)

Time frame: During taVNS Phase 1 application

Phase 1 Blood Pressure Immediately after taVNS is stopped

Systolic and Diastolic Blood Pressure (mmHg)

Time frame: Immediately after taVNS Phase 1 application is stopped

Phase 1 Blood Pressure 5 minutes after taVNS is stopped

Systolic and Diastolic Blood Pressure (mmHg)

Time frame: 5 minutes after taVNS Phase 1 application is stopped

Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Admission

Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record

Time frame: Admission to rehabilitation

Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Discharge

Total score on the IRF-PAI Section GG mobility. Scores range from 15 to 90. Extracted from the medical record

Time frame: Immediately after discharge from rehabilitation

Central Contacts

Rachel E Cowan, PhD

CONTACT

2059345034recowan@uabmc.edu

Christopher Williamson, MBA

CONTACT

2059343776cmwilliamson@uabmc.edu
Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.