Status:
RECRUITING
Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU
Lead Sponsor:
Washington University School of Medicine
Conditions:
Acute Neurological Injury
Acute Medical Conditions
Eligibility:
All Genders
18+ years
Phase:
NA
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 i...
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 st...
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
Key Trial Info
Start Date :
September 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 23 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT07219108
Start Date
September 24 2025
End Date
September 23 2027
Last Update
October 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110