Ear (auricular) vagus nerve stimulation to speed recovery after acute neurocritical illness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults admitted to the NeuroICU within 36 hours of an acute neurological or medical event are randomized to transcutaneous auricular vagus nerve stimulation (taVNS) or sham stimulation. Blood samples for inflammatory markers are collected on admission and serially during the hospital stay while clinicians track infections, need for tracheostomy, vital signs, blood glucose, peri-hematomal edema, and related interventions. Outcomes include rates of hospital-acquired infection, tracheostomy, ICU and hospital length of stay, physiologic measures, inflammatory marker trends, discharge destination, functional scores up to one year, and a health economic cost analysis. No additional clinic visits are required specifically for the research protocol.

Why it matters

Who can join: the full rules

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
  * Other brain or spinal cord injury or lesion requiring intensive care

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

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Study coordinator: Raj Dhar, MD
• Email: dharr@wustl.edu
• Phone: 314-362 2999

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Alert frequency and nurse/patient satisfaction with a wireless continuous vital-sign monitoring app

  This pilot will test whether a wearable continuous vital-sign monitoring system and its app work well and are acceptable to adult patients and nurses on general wards after surgery or acute medical admission.

  Recruiting University Hospital Bispebjerg and Frederiksberg · Cleveland, Ohio and 4 other locations · NCT06289699

• Cognitive changes after bariatric surgery using VR Neurotracker and Neuropsi testing

  This study will test whether bariatric surgery combined with virtual‑reality Neurotracker sessions improves thinking and memory in adults with morbid obesity scheduled for surgery.

  Recruiting Hospital General de México Dr. Eduardo Liceaga · Montreal, Quebec and 1 other locations · NCT07229924

• Short-term effects of ultra-processed foods on metabolism

  This project will test whether a short-term diet high in ultra-processed foods versus a nutrient- and energy-matched low-UPF diet changes appetite and how much adults with BMI 18.5–30 eat.

  Recruiting Göteborg University · Gothenburg · NCT07213245

• Validating lab assays, IV catheter techniques, and devices for endocrine, cardiometabolic, and musculoskeletal conditions

  This project will test whether laboratory assays, IV catheter methods, and equipment give consistent, reliable results in adults with or without obesity-related, metabolic, or musculoskeletal conditions.

  Recruiting University of Missouri-Columbia · Columbia, Missouri · NCT07083557

• Improving team-based biopsychosocial training so clinics can deliver recommended obesity care

  This project will test two training methods to help clinic teams (primary care clinicians, behavioral health staff, dietitians, and community health workers) deliver USPSTF-recommended obesity care to patients at Federally Qualified Health Centers.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT07049861

• See if same day discharge after bariatric surgery is safe for select patients

  This trial tests whether people having sleeve gastrectomy or gastric bypass can go home the same day or should stay at least one night, to see if ER visits within a week differ.

  Recruiting Vanderbilt University Medical Center · Nashville, Tennessee · NCT07011628

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.