An interventional study of Auricular Vagus Nerve Stimulation and Sham Auricular Vagus nerve Stimulation in Acute Neurological Injury and Acute Medical Conditions, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
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 study is to determine if transcutaneous auricular VNS will impact 1) the occurrence of hospital-acquired infections, 2) the need for tracheostomy due to prolonged intubation, 3) the effect on hospital-stay physiology (e.g., vital signs and blood glucose metrics), and 4) inflammatory markers in the blood, and 5) the health economics.
This study will involve randomizing patients to stimulation with VNS, or sham stimulation. Blood samples for inflammatory marker analysis will be collected upon admission and serially throughout the patient's admission. Clinical events tracked during the hospital stay include the occurrence of hospital-acquired infections, tracheostomy, changes in vital signs and blood glucose, development of peri-hematomal edema, and interventions for edema (medical or surgical). Outcomes following admission will include intensive care unit and hospital stay, cost analysis of hospital stay, discharge destination, functional scores at discharge, and at follow-up visits for up to 1 year after discharge. No additional appointments will be made specially for the research study.
191 studies on the registry are indexed under Pathologic Processes; 32 are open to participants now.
This study's planned enrollment of 160 is above the median of 84 across 149 interventional studies indexed under Pathologic Processes.
Browse Pathologic Processes studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 7, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Presence of at least one predictor of critical illness and/or severe brain / spinal cord injury:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive twice-daily auricular vagal nerve stimulation
Device: Auricular Vagus Nerve Stimulation
Participants will have an auricular vagal nerve stimulator placed in their ear twice daily, without the stimulation applied
Device: Sham Auricular Vagus nerve Stimulation
Transcutaneous auricular vagal nerve stimulation
Transcutaneous auricular vagal nerve ear clip applied without current/stimulation
Assessment of the need for tracheostomy.
Quantification of patients who need tracheostomy due to prolonged intubation.
Time frame: 14 days
Occurrence of hospital-acquired infections
Data will be collected from medical records. Infections will include ventilator-associated pneumonia, catheter-associated urinary tract infections, bloodstream infection, clostridium difficile, and ventriculitis.
Time frame: 14 days
Changes in heart rate/heart trace
Evaluation of changes in centrally monitored heart rate/heart trace to calculate heart rate variability and QT interval.
Time frame: 14 days
Blood glucose measurement
Daily evaluation of blood glucose (mg/dL)
Time frame: 14 days
Insulin requirement
Assessment of daily insulin requirement (Units)
Time frame: 14 days
Hospital length of stay
Total length of stay in the hospital, and in the intensive care unit
Time frame: Through hospital admission, average 14 days
Neurological outcome
Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
Time frame: 1 year
Discharge destination
Patient discharge destination (ie, home, acute rehab)
Time frame: After hospital discharge, on average 14 days after admission.
Cost of ICU stay
Evaluation of total ICU cost of stay ($)
Time frame: Through hospital admission, average 14 days
Cost of Hospital Admission
Evaluation of total hospital admission cost of stay ($)
Time frame: Through hospital admission, average 14 days
Change in the inflammatory markers TNF-α, IL-6, IL-10, and IFN-γ in plasma
Blood samples collected on days 1, 4, 7, 10, and 14 (Day 1 serves as baseline, prior to first treatment). Inflammatory markers will be reported in pg/mL.
Time frame: 14 days
Change in inflammatory markers in cerebrospinal fluid
rebrospinal fluid samples collected on days 1, 4, 7, 10, and 14 to evaluate for TNF-α, IL-6, IL-10, and IFN-γ . Inflammatory markers will be reported in pg/mL.
Time frame: 14 days
Cerebral Edema
Assessment of cerebral edema on each medically indicated and obtained head CT scan through assessment of selective sulcal volume (SSV)
Time frame: 14 days
Neurological outcome at discharge and first follow-up
Disease-specific neurological outcome metric at discharge and first follow-up. Glasgow Coma Scale (GCS, maximum score: 15; minimum score: 3; better outcomes have higher scores).
Time frame: up to 1 year.
Neurological Outcome at discharge and first follow-up
Disease-specific neurological outcome metric at discharge and first follow-up. Glasgow Outcome Scale-Extended (GOSE, maximum score: 8; minimum score 1; better outcomes have higher scores).
Time frame: up to 1 year.
Neurological Outcome at discharge and first follow-up
Disease-specific neurological outcome metric at discharge and first follow-up. Hemorrhagic stroke Glasgow Coma Scale (GCS, maximum score: 15; minimum score: 3; better outcomes have higher scores).
Time frame: Up to 1 year.
Neurological Outcome at discharge and first follow-up.
Disease-specific neurological outcome metric at discharge and first follow-up. National Institutes of Health Stroke Scale (NIHSS, maximum score: 42; minimum score: 1; better outcomes have lower scores).
Time frame: Up to 1 year.
Diagnosis of hospital-acquired infections
Binary assessment of hospital-acquired infections (ventilator-associated pneumonia, catheter associated urinary tract infection, Clostridium difficile infection, ventriculitis) diagnosis acquired from hospital databases. (Yes or No rating, better outcomes associated with No).
Time frame: Through hospital admission, average 14 days
Use of a ventilator
Quantification of days on ventilator
Time frame: Through hospital admission, average 14 days
Plan to share: No
Started Sep 2025 (actual). Primary completion is estimated for Sep 2027, 23 months after the start.
Of 37 interventional studies with no phase under Pathologic Processes, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 41. This study's planned 23 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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