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Recruiting NCT07219108

NCT07219108 Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU

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Clinical Trial Summary
NCT ID NCT07219108
Status Recruiting
Phase
Sponsor Washington University School of Medicine
Condition Acute Neurological Injury
Study Type INTERVENTIONAL
Enrollment 160 participants
Start Date 2025-09-24
Primary Completion 2027-09-23

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Auricular Vagus Nerve StimulationSham Auricular Vagus nerve Stimulation

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 160 participants in total. It began in 2025-09-24 with a primary completion date of 2027-09-23.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility 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

Contact & Investigator

Central Contact

Raj Dhar, MD

✉ dharr@wustl.edu

📞 314-362 2999

Principal Investigator

Eric Leuthardt, MD MBA

STUDY CHAIR

Washington University School of Medicine

Frequently Asked Questions

Who can join the NCT07219108 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Neurological Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07219108 currently recruiting?

Yes, NCT07219108 is actively recruiting participants. Contact the research team at dharr@wustl.edu for enrollment information.

Where is the NCT07219108 trial being conducted?

This trial is being conducted at St Louis, United States.

Who is sponsoring the NCT07219108 clinical trial?

NCT07219108 is sponsored by Washington University School of Medicine. The principal investigator is Eric Leuthardt, MD MBA at Washington University School of Medicine. The trial plans to enroll 160 participants.

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