Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU
Recruiting
N/AInterventional Study
Acute Neurological InjuryAcute Medical Conditions
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
160 (estimated)
Sponsor
Washington University School of Medicine · Other
Who this trial is looking for
This trial is looking for patients with acute neurological injuries who are admitted to the NeuroICU. Participants will receive taVNS treatment to see if it helps improve their recovery and reduce hospital stay.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older.
I was admitted to the NeuroICU within 36 hours of a medical issue.
I can give consent or have a legal representative who can.
I have at least one predictor of critical illness, like a low Glasgow Coma Scale score.
I require ongoing mechanical ventilation.
I have been diagnosed with severe brain or spinal cord injury.
I have had a stroke with a high NIH stroke scale score.
You may not be able to join if
I am undergoing cancer treatment.
I have an implanted electrical device like a pacemaker.
I have sustained bradycardia with a heart rate under 50 bpm.
I am at risk of imminent death.
I am pregnant.
I have COVID-19.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 brai…
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
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