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

This study is testing a treatment called transauricular vagus nerve stimulation (taVNS) for people who have recently experienced a spinal cord injury (SCI). taVNS uses a small device placed on your ear to gently stimulate a nerve. Researchers want to see if taVNS is safe and comfortable for you, and if it can be safely added to your regular mobility therapy. They also want to learn if taVNS might help improve your ability to move. This study is for adults aged 18 to 89 with a recent SCI who are undergoing inpatient rehabilitation. The study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This is an interventional study with an unclear phase, planning to enroll 50 participants. It involves two parts.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints measure hypotension symptoms immediately before, during, and immediately after taVNS application.

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NCT07562113

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

Not Yet Recruiting
PHASE1Ages 18–89InterventionalTreatment
University of Alabama at Birmingham
~50 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Transauricular vagus nerve stimulation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 Hypotension Symptoms Immediately before taVNS is applied
Measured over Immediately before Phase 1 taVNS application
+5 more outcomes measured
Spinal Cord Injuries (Complete and Incomplete)
1 sites across 1 states
Alabama1
  • Rachel E Cowan, PhD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

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Eligibility criteria

Inclusion

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

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 1 Hypotension Symptoms Immediately before taVNS is appliedImmediately 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

  • Phase 1 Hypotension Symptoms during taVNS spplicationDuring 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

  • Phase 1 Hypotension Symptoms Immediately after taVNS is stoppedImmediately 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

  • Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped5 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

  • Phase 1 taVNS Tolerability surveyWithin 48 hours of competing Phase 1 taVNS

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

  • Phase 2 taVNS Tolerability surveyWithin 48 hours of completing Phase 2 taVNS

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