Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU

This study is testing if transcutaneous auricular vagus nerve stimulation (taVNS) can help patients in the NeuroICU recover better. taVNS involves a device that stimulates a nerve in your ear. We want to see if taVNS can reduce hospital-acquired infections, decrease the need for a breathing tube (tracheostomy), and improve vital signs like heart rate. We are also looking at the economic benefits. You might be able to join if you are 18 or older, admitted to the NeuroICU within 36 hours for an acute medical condition, and have certain signs of critical illness or brain/spinal cord injury. The study aims to enroll 160 participants. The current recruitment status is unclear.

Study design
This interventional study will involve randomly assigning participants to receive either transcutaneous auricular vagal nerve stimulation or a sham (inactive) stimulation.
What's involved
Blood samples will be collected upon admission and throughout your hospital stay. Clinical events like infections, tracheostomy, and changes in vital signs will be tracked during your hospital stay. No additional appointments will be made specifically for this research study.
Compensation
Not stated in the trial record.
Follow-up
Outcomes will be tracked during your hospital stay, at discharge, and at follow-up visits for up to 1 year after discharge.

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NCT07219108

Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU

Recruiting
NAAges 18+InterventionalTreatment
Washington University School of Medicine
~160 participants
Updated 2025-10-21 on ClinicalTrials.gov
What's tested:Auricular Vagus Nerve StimulationSham Auricular Vagus nerve Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of the need for tracheostomy.
Measured over 14 days
+9 more outcomes measured
Acute Neurological Injury
Acute Medical Conditions
1 sites across 1 states
Missouri1
  • Eric Leuthardt, MD MBA · STUDY_CHAIR · Washington University School of Medicine

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Eligibility criteria

Inclusion

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

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
  • Assessment of the need for tracheostomy.14 days

    Quantification of patients who need tracheostomy due to prolonged intubation.

  • Occurrence of hospital-acquired infections14 days

    Data will be collected from medical records. Infections will include ventilator-associated pneumonia, catheter-associated urinary tract infections, bloodstream infection, clostridium difficile, and ventriculitis.

  • Changes in heart rate/heart trace14 days

    Evaluation of changes in centrally monitored heart rate/heart trace to calculate heart rate variability and QT interval.

  • Blood glucose measurement14 days

    Daily evaluation of blood glucose (mg/dL)

  • Insulin requirement14 days

    Assessment of daily insulin requirement (Units)

  • Hospital length of stayThrough hospital admission, average 14 days

    Total length of stay in the hospital, and in the intensive care unit

  • Neurological outcome1 year

    Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)

  • Discharge destinationAfter hospital discharge, on average 14 days after admission.

    Patient discharge destination (ie, home, acute rehab)

  • Cost of ICU stayThrough hospital admission, average 14 days

    Evaluation of total ICU cost of stay ($)

  • Cost of Hospital AdmissionThrough hospital admission, average 14 days

    Evaluation of total hospital admission cost of stay ($)