Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU

NCT07219108 | Recruiting FDA Device

• 1 other identifier: 202507232
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• Assessment of the need for tracheostomy.

  Quantification of patients who need tracheostomy due to prolonged intubation.

  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.

  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.

  14 days

• Blood glucose measurement

  Daily evaluation of blood glucose (mg/dL)

  14 days

• Insulin requirement

  Assessment of daily insulin requirement (Units)

  14 days

• Hospital length of stay

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

  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)

  1 year

• Discharge destination

  Patient discharge destination (ie, home, acute rehab)

  After hospital discharge, on average 14 days after admission.

• Cost of ICU stay

  Evaluation of total ICU cost of stay ($)

  Through hospital admission, average 14 days

• Cost of Hospital Admission

  Evaluation of total hospital admission cost of stay ($)

  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

  14 days

• Change in inflammatory markers in cerebrospinal fluid

  14 days

• Cerebral Edema

  14 days

• Neurological outcome at discharge and first follow-up

  up to 1 year.

• Neurological Outcome at discharge and first follow-up

  up to 1 year.

Study Arms (2)

Auricular VNS Stimulation

EXPERIMENTAL

Participants receive twice-daily auricular vagal nerve stimulation

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

Device: Sham Auricular Vagus nerve Stimulation

Interventions

Auricular Vagus Nerve Stimulation DEVICE

Transcutaneous auricular vagal nerve stimulation

Auricular VNS Stimulation

Sham Auricular Vagus nerve Stimulation DEVICE

Transcutaneous auricular vagal nerve ear clip applied without current/stimulation

Sham Auricular VNS Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 39786346 BACKGROUND

• Huguenard 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.

  PMID: 39178291 BACKGROUND

• Huguenard 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.

  PMID: 38746275 BACKGROUND

MeSH Terms

Conditions

Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Hemorrhage

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Cardiovascular Diseases

Study Officials

• Eric Leuthardt, MD MBA

  Washington University School of Medicine

  STUDY CHAIR

Central Study Contacts

Raj Dhar, MD

CONTACT

314-362 2999; dharr@wustl.edu

Anna Huguenard, MD

CONTACT

314-362-3570; ahuguenard@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: All participants will be fitted with an auricular stimulator, but blinded to whether they are receiving stimulation or not. Outcome scores and measures will be assessed and recorded by clinicians and research team members blinded to the treatment arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to either stimulation or sham stimulation arms

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 21, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): September 23, 2027
• Study Completion (Estimated): September 23, 2027
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)