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

NCT07562113 | Not Yet Recruiting Phase 1

• 2 other identifiers: IRB-300015896UAB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To find out whether taVNS is safe and comfortable for people with a recent spinal cord injury.
2. 2.To get information on whether taVNS may help improve mobility when compared to people who completed rehabilitation before this study started.

Conditions

Spinal Cord Injuries (Complete and Incomplete)

Keywords

vagus nerve stimulation; spinal cord injuries; Rehabilitation; walking

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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

  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

  Within 48 hours of completing Phase 2 taVNS

Secondary Outcomes (6)

• Phase 1 Blood Pressure Immediately before taVNS is applied

  Immediately before taVNS Phase 1 application is applied

• Phase 1 Blood Pressure during taVNS application

  During taVNS Phase 1 application

• Phase 1 Blood Pressure Immediately after taVNS is stopped

  Immediately after taVNS Phase 1 application is stopped

• Phase 1 Blood Pressure 5 minutes after taVNS is stopped

  5 minutes after taVNS Phase 1 application is stopped

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

  Admission to rehabilitation

Study Arms (1)

taVNS application

EXPERIMENTAL

This is a single arm study with two Phases. In Phase 1 taVNS will be applied bilaterally for a brief period while the individual is in inpatient rehabilitation In Phase 2 taVNS will be applied for a brief period immediately before each mobility therapy session while the period is in inpatient rehabilitation. The mobility therapy sessions are routine care. Frequency and intensity of these sessions are determined by the therapists. All individuals must complete Phase 1 before starting Phase 2. Not all individuals who complete Phase 1 will be eligible for Phase 2. Please see eligibility criteria for more details.

Device: Transauricular vagus nerve stimulation

Interventions

Transauricular vagus nerve stimulation DEVICE

bilateral transauricular vagal nerve stimulation

Also known as: taVNS

taVNS application

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Rachel E Cowan, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel E Cowan, PhD

CONTACT

2059345034; recowan@uabmc.edu

Christopher Williamson, MBA

CONTACT

2059343776; cmwilliamson@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: May 1, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)