Recruiting

taVNS

Sponsor:

Washington University School of Medicine

Code:

NCT07219108

Conditions

Acute Neurological Injury

Acute Medical Conditions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Auricular Vagus Nerve Stimulation

Sham Auricular Vagus nerve Stimulation

Study Details

Brief summary:

This study will demonstrate the impact of taVNS on reducing adverse events in NeuroICU patients, determine if taVNS reduces length of stay, and quantify the economic benefits of taVNS implementation in a broader neurocritical care population.

Conditions

Acute Neurological Injury

Acute Medical Conditions

Study ID

NCT07219108

Start date

Sep 24, 2025

Status verified date

Oct, 2025

Completion date

Sep 23, 2027

Anticipated

Primary completion date

Sep 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18
  • Admission to the NeuroICU within 36 hours of onset of an acute medical condition.
  • Patient or authorized legal representative should be able to provide consent within 36 hours of ICU arrival
  • Presence of at least one predictor of critical illness and/or severe brain / spinal cord injury:

  • Glasgow Coma Scale GCS >3 \& <= 12 at admission
  • NIH stroke scale of 6 or greater
  • Requirement for ongoing mechanical ventilation
  • Requirement for ongoing vasopressor support
  • Diagnosis of subarachnoid hemorrhage
  • Diagnosis of intracerebral hemorrhage with hematoma volume > 5 ml
  • Diagnosis of moderate-severe traumatic brain injury (GCS >3 \& <= 12)
  • Refractory Status epilepticus requiring continuous sedative infusions

Exclusion Criteria:

  • Systemic immunosuppression
  • Receiving ongoing cancer therapy
  • Implanted electrical device (e.g., pacemaker, stimulator)
  • Bradycardia on admission (Sustained bradycardia on arrival with a heart rate < 50 bpm for >5 minutes)
  • Risk of imminent death or limitation of care (e.g., Glasgow Coma Scale of 3, pupillary dilatation)
  • Expected ICU stay of less than 72 hours, as determined by attending physician or ICU fellow
  • Pregnancy
  • COVID-19

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Auricular VNS Stimulation

Participants receive twice-daily auricular vagal nerve stimulation

sham comparator: Sham Auricular VNS Stimulation

Participants will have an auricular vagal nerve stimulator placed in their ear twice daily, without the stimulation applied

Interventions

Auricular Vagus Nerve Stimulation

Transcutaneous auricular vagal nerve stimulation

Sham Auricular Vagus nerve Stimulation

Transcutaneous auricular vagal nerve ear clip applied without current/stimulation

Primary outcome measure

  • Assessment of the need for tracheostomy. [ Time Frame: 14 days ]
  • Occurrence of hospital-acquired infections [ Time Frame: 14 days ]
  • Changes in heart rate/heart trace [ Time Frame: 14 days ]
  • Blood glucose measurement [ Time Frame: 14 days ]
  • Insulin requirement [ Time Frame: 14 days ]
  • Hospital length of stay [ Time Frame: Through hospital admission, average 14 days ]
  • Neurological outcome [ Time Frame: 1 year ]
  • Discharge destination [ Time Frame: After hospital discharge, on average 14 days after admission. ]
  • Cost of ICU stay [ Time Frame: Through hospital admission, average 14 days ]
  • Cost of Hospital Admission [ Time Frame: Through hospital admission, average 14 days ]

Central Contacts and Locations

Central contacts

Raj Dhar, MD

314-362 2999dharr@wustl.edu

Anna Huguenard, MD

314-362-3570ahuguenard@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Juliana Amaral Passipieri, PhD

314-747-1443ajuliana@wustl.edu

Elma Heric, BS

314-362-3570elmah@wustl.edu

Principal Investigator:

Eric Leuthardt, MD MBA

More Information

Sponsor

Washington University School of Medicine

Last update posted

Oct 21, 2025

Last verified

Oct, 2025

Keywords

  • vagal nerve stimulation
  • pathologic process
  • acute medical condition
  • brain diseases
  • central nervous system diseases
  • spine cord injury
  • vascular diseases
  • hemorrhage
  • acute neurological condition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-10-21.