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Not yet recruiting NCT07562113

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

Phase I / Phase II Interventional Spinal Cord Injuries (Complete and Incomplete)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transauricular vagus nerve stimulation.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries (Complete and Incomplete). Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Interventions

  • Device Transauricular vagus nerve stimulation
    bilateral transauricular vagal nerve stimulation

Primary outcome measures

  • Phase 1 Hypotension Symptoms Immediately before taVNS is applied [Time frame: Immediately before Phase 1 taVNS application]
  • Phase 1 Hypotension Symptoms during taVNS spplication [Time frame: During application of Phase 1 taVNS]
  • Phase 1 Hypotension Symptoms Immediately after taVNS is stopped [Time frame: Immediately after Phase 1 taVNS is stopped]
  • Phase 1 Hypotension Symptoms 5 minutes after taVNS is stopped [Time frame: 5 minutes after Phase 1 taVNS is stopped]
  • Phase 1 taVNS Tolerability survey [Time frame: Within 48 hours of competing Phase 1 taVNS]
  • Phase 2 taVNS Tolerability survey [Time frame: Within 48 hours of completing Phase 2 taVNS]
Secondary outcome measures (6)
  • Phase 1 Blood Pressure Immediately before taVNS is applied [Time frame: Immediately before taVNS Phase 1 application is applied]
  • Phase 1 Blood Pressure during taVNS application [Time frame: During taVNS Phase 1 application]
  • Phase 1 Blood Pressure Immediately after taVNS is stopped [Time frame: Immediately after taVNS Phase 1 application is stopped]
  • Phase 1 Blood Pressure 5 minutes after taVNS is stopped [Time frame: 5 minutes after taVNS Phase 1 application is stopped]
  • Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Admission [Time frame: Admission to rehabilitation]
  • Phase 2 IRF-PAI Section GG Total Mobility Score Rehabilitation Discharge [Time frame: Immediately after discharge from rehabilitation]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT07562113 · IRB-300015896 · UAB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗