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NCT Number: NCT07562113

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

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.

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Key information

Conditions

Spinal Cord Injuries (Complete and Incomplete) Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transauricular Vagus Nerve Stimulation

Device

bilateral transauricular vagal nerve stimulation

Other names: taVNS

Primary outcomes

  1. Phase 1 Hypotension Symptoms Immediately before taVNS is applied

    Time frame: Immediately before Phase 1 taVNS application

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

  2. Phase 1 Hypotension Symptoms during taVNS spplication

    Time frame: During application of Phase 1 taVNS

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

  3. Phase 1 Hypotension Symptoms Immediately after taVNS is stopped

    Time frame: Immediately after Phase 1 taVNS is stopped

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

  4. Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped

    Time frame: 5 minutes after Phase 1 taVNS is stopped

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

  5. Phase 1 taVNS Tolerability survey

    Time frame: Within 48 hours of competing Phase 1 taVNS

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

  6. Phase 2 taVNS Tolerability survey

    Time frame: Within 48 hours of completing Phase 2 taVNS

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

Secondary outcomes

  1. Phase 1 Blood Pressure Immediately before taVNS is applied

    Time frame: Immediately before taVNS Phase 1 application is applied

    Systolic and Diastolic Blood Pressure (mmHg)

  2. Phase 1 Blood Pressure during taVNS application

    Time frame: During taVNS Phase 1 application

    Systolic and Diastolic Blood Pressure (mmHg)

  3. Phase 1 Blood Pressure Immediately after taVNS is stopped

    Time frame: Immediately after taVNS Phase 1 application is stopped

    Systolic and Diastolic Blood Pressure (mmHg)

  4. Phase 1 Blood Pressure 5 minutes after taVNS is stopped

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

    Systolic and Diastolic Blood Pressure (mmHg)

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

    Time frame: Admission to rehabilitation

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

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

    Time frame: Immediately after discharge from rehabilitation

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

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Williamson, MBA

CONTACT

[email protected]

2059343776

Rachel E Cowan, PhD

CONTACT

[email protected]

2059345034

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Pilot Investigation of Transauricular Vagal Nerve Stimulation Safety and Feasibility in Acute Incomplete Spinal Cord Injury Rehabilitation

Acronym: PIVOTS-Rehab

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 1, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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