Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU (NCT07219108) | Clinical Trial Compass
RecruitingNot Applicable
Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU
United States160 participantsStarted 2025-09-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of the need for tracheostomy.
Timeframe: 14 days
2
Occurrence of hospital-acquired infections
Timeframe: 14 days
3
Changes in heart rate/heart trace
Timeframe: 14 days
4
Blood glucose measurement
Timeframe: 14 days
5
Insulin requirement
Timeframe: 14 days
6
Hospital length of stay
Timeframe: Through hospital admission, average 14 days
7
Neurological outcome
Timeframe: 1 year
8
Discharge destination
Timeframe: After hospital discharge, on average 14 days after admission.