Ear (auricular) vagus nerve stimulation to speed recovery after acute neurocritical illness
The TAVERN Trial: Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU - A Study of Clinical Outcomes and Cost Reduction
This trial will test whether noninvasive ear (auricular) vagus nerve stimulation helps adults admitted to the NeuroICU have fewer infections, need fewer tracheostomies, and leave the hospital sooner.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT07219108 on ClinicalTrials.gov |
What this trial studies
Adults admitted to the NeuroICU within 36 hours of an acute neurological or medical event are randomized to transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation. Blood samples for inflammatory markers are collected on admission and serially during the hospital stay while clinicians track infections, need for tracheostomy, vital signs, blood glucose, peri-hematomal edema, and related interventions. Outcomes include rates of hospital-acquired infection, tracheostomy, ICU and hospital length of stay, physiologic measures, inflammatory marker trends, discharge destination, functional scores up to one year, and a health economic cost analysis. No additional clinic visits are required specifically for the research protocol.
Who should consider this trial
Good fit: Adults (≥18 years) admitted to the NeuroICU within 36 hours of an acute medical or neurological event who meet at least one critical-illness predictor (GCS 4–12, NIH Stroke Scale ≥6, ongoing mechanical ventilation, vasopressor support, subarachnoid hemorrhage, intracerebral hemorrhage with >5 mL hematoma, moderate–severe TBI, or refractory status epilepticus) are ideal candidates.
Not a fit: Patients with systemic immunosuppression, active cancer therapy, implanted electrical devices (e.g., pacemaker), or sustained bradycardia on admission are excluded and are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, taVNS could reduce infection rates and prolonged intubation, shorten ICU and hospital stays, and lower overall care costs for neurocritical patients.
How similar studies have performed: Animal studies and some human work with implantable VNS show anti-inflammatory effects, but transcutaneous auricular VNS in acute neurocritical care is relatively novel with limited clinical data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Raj Dhar, MD
- Email: dharr@wustl.edu
- Phone: 314-362 2999
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.