Acute Neurological InjuryTAVERNNCT07219108
Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU
A study testing Auricular Vagus Nerve Stimulation in people with Acute Neurological Injury and Acute Medical Conditions, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Neurological Injury, Acute Medical Conditions
- What is being tested?
- Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2025to 23 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
- Other brain or spinal cord injury or lesion requiring intensive care
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Juliana Amaral Passipieri, PhD, 314-747-1443, ajuliana@wustl.edu
Elma Heric, BS, 314-362-3570, elmah@wustl.edu
About this study
Official title: The TAVERN Trial: Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU - A Study of Clinical Outcomes and Cost Reduction
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.
Read the detailed description
Vagal nerve stimulation (VNS) has been studied as a novel method of reducing inflammation, and it has been successfully used in animal models of inflammatory conditions. The purpose of the proposed study is to determine if transcutaneous auricular VNS will impact 1) the occurrence of hospital-acquired infections, 2) the need for tracheostomy due to prolonged intubation, 3) the effect on hospital-stay physiology (e.g., vital signs and blood glucose metrics), and 4) inflammatory markers in the blood, and 5) the health economics.
This study will involve randomizing patients to stimulation with VNS, or sham stimulation. Blood samples for inflammatory marker analysis will be collected upon admission and serially throughout the patient's admission. Clinical events tracked during the hospital stay include the occurrence of hospital-acquired infections, tracheostomy, changes in vital signs and blood glucose, development of peri-hematomal edema, and interventions for edema (medical or surgical). Outcomes following admission will include intensive care unit and hospital stay, cost analysis of hospital stay, discharge destination, functional scores at discharge, and at follow-up visits for up to 1 year after discharge. No additional appointments will be made specially for the research study.
- Being tested
- Auricular Vagus Nerve Stimulation, Sham Auricular Vagus nerve Stimulation
- Keywords
- vagal nerve stimulation, pathologic process, acute medical condition, brain diseases, central nervous system diseases, spine cord injury, vascular diseases, hemorrhage, acute neurological condition
- Medical subject headings
- Pathologic Processes, Brain Diseases, Central Nervous System Diseases, Vascular Diseases, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Vagus Nerve StimulationDevice
Transcutaneous auricular vagal nerve stimulation
Sham Auricular Vagus nerve StimulationDevice
Transcutaneous auricular vagal nerve ear clip applied without current/stimulation
| Study group | Role | What they receive |
|---|---|---|
| Auricular VNS Stimulation | Experimental | Participants receive twice-daily auricular vagal nerve stimulation Receives: Device: Auricular Vagus Nerve Stimulation |
| Sham Auricular VNS Stimulation | Sham comparator | Participants will have an auricular vagal nerve stimulator placed in their ear twice daily, without the stimulation applied Receives: Device: Sham Auricular Vagus nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the need for tracheostomy.
Quantification of patients who need tracheostomy due to prolonged intubation.
Measured: 14 days
Occurrence of hospital-acquired infections
Data will be collected from medical records. Infections will include ventilator-associated pneumonia, catheter-associated urinary tract infections, bloodstream infection, clostridium difficile, and ventriculitis.
Measured: 14 days
Changes in heart rate/heart trace
Evaluation of changes in centrally monitored heart rate/heart trace to calculate heart rate variability and QT interval.
Measured: 14 days
Blood glucose measurement
Daily evaluation of blood glucose (mg/dL)
Measured: 14 days
Insulin requirement
Assessment of daily insulin requirement (Units)
Measured: 14 days
Hospital length of stay
Total length of stay in the hospital, and in the intensive care unit
Measured: Through hospital admission, average 14 days
Neurological outcome
Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
Measured: 1 year
Discharge destination
Patient discharge destination (ie, home, acute rehab)
Measured: After hospital discharge, on average 14 days after admission.
Cost of ICU stay
Evaluation of total ICU cost of stay ($)
Measured: Through hospital admission, average 14 days
Cost of Hospital Admission
Evaluation of total hospital admission cost of stay ($)
Measured: Through hospital admission, average 14 days
Secondary outcomes (9)
Change in the inflammatory markers TNF-α, IL-6, IL-10, and IFN-γ in plasma
Blood samples collected on days 1, 4, 7, 10, and 14 (Day 1 serves as baseline, prior to first treatment). Inflammatory markers will be reported in pg/mL.
Measured: 14 days
Change in inflammatory markers in cerebrospinal fluid
rebrospinal fluid samples collected on days 1, 4, 7, 10, and 14 to evaluate for TNF-α, IL-6, IL-10, and IFN-γ . Inflammatory markers will be reported in pg/mL.
Measured: 14 days
Cerebral Edema
Assessment of cerebral edema on each medically indicated and obtained head CT scan through assessment of selective sulcal volume (SSV)
Measured: 14 days
Neurological outcome at discharge and first follow-up
Disease-specific neurological outcome metric at discharge and first follow-up. Glasgow Coma Scale (GCS, maximum score: 15; minimum score: 3; better outcomes have higher scores).
Measured: up to 1 year.
Neurological Outcome at discharge and first follow-up
Disease-specific neurological outcome metric at discharge and first follow-up. Glasgow Outcome Scale-Extended (GOSE, maximum score: 8; minimum score 1; better outcomes have higher scores).
Measured: up to 1 year.
Neurological Outcome at discharge and first follow-up
Disease-specific neurological outcome metric at discharge and first follow-up. Hemorrhagic stroke Glasgow Coma Scale (GCS, maximum score: 15; minimum score: 3; better outcomes have higher scores).
Measured: Up to 1 year.
Neurological Outcome at discharge and first follow-up.
Disease-specific neurological outcome metric at discharge and first follow-up. National Institutes of Health Stroke Scale (NIHSS, maximum score: 42; minimum score: 1; better outcomes have lower scores).
Measured: Up to 1 year.
Diagnosis of hospital-acquired infections
Binary assessment of hospital-acquired infections (ventilator-associated pneumonia, catheter associated urinary tract infection, Clostridium difficile infection, ventriculitis) diagnosis acquired from hospital databases. (Yes or No rating, better outcomes associated with No).
Measured: Through hospital admission, average 14 days
Use of a ventilator
Quantification of days on ventilator
Measured: Through hospital admission, average 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start24 Sep 2025
- Primary completion23 Sep 2027 (estimated)
- Study completion23 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Neurological InjuryStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either stimulation or sham stimulation arms
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Leuthardt, MD MBA, Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219108
- Sponsor's protocol ID
- 202507232
- Acronym
- TAVERN
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tan G, Huguenard AL, Donovan KM, Demarest P, Liu X, Li Z, Adamek M, Lavine K, Vellimana AK, Kummer TT, Osbun JW, Zipfel GJ, Brunner P, Leuthardt EC. The effect of transcutaneous auricular vagus nerve stimulation on cardiovascular function in subarachnoid hemorrhage patients: A randomized trial. Elife. 2025 Jan 9;13:RP100088. doi: 10.7554/eLife.100088.
PubMed 39786346Huguenard A, Tan G, Johnson G, Adamek M, Coxon A, Kummer T, Osbun J, Vellimana A, Limbrick D Jr, Zipfel G, Brunner P, Leuthardt E. Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial. PLoS One. 2024 Aug 23;19(8):e0301154. doi: 10.1371/journal.pone.0301154. eCollection 2024.
PubMed 39178291Huguenard AL, Tan G, Rivet DJ, Gao F, Johnson GW, Adamek M, Coxon AT, Kummer TT, Osbun JW, Vellimana AK, Limbrick DD, Zipfel GJ, Brunner P, Leuthardt EC. Auricular Vagus Nerve Stimulation Mitigates Inflammation and Vasospasm in Subarachnoid Hemorrhage: A Randomized Trial. medRxiv [Preprint]. 2024 May 1:2024.04.29.24306598. doi: 10.1101/2024.04.29.24306598.
PubMed 38746275