Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular VNS Stimulation | Experimental | Participants receive twice-daily auricular vagal nerve stimulation |
|
| Sham Auricular VNS Stimulation | Sham Comparator | Participants will have an auricular vagal nerve stimulator placed in their ear twice daily, without the stimulation applied |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular Vagus Nerve Stimulation | Device | Transcutaneous auricular vagal nerve stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the need for tracheostomy. | Quantification of patients who need tracheostomy due to prolonged intubation. | 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. | 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. | 14 days |
| Blood glucose measurement | Daily evaluation of blood glucose (mg/dL) | 14 days |
| Insulin requirement | Assessment of daily insulin requirement (Units) | 14 days |
| Hospital length of stay | Total length of stay in the hospital, and in the intensive care unit | 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) | 1 year |
| Discharge destination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
| Change in inflammatory markers in cerebrospinal fluid |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raj Dhar, MD | Contact | 314-362 2999 | dharr@wustl.edu | |
| Anna Huguenard, MD | Contact | 314-362-3570 | ahuguenard@wustl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eric Leuthardt, MD MBA | Washington University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39786346 | Background | Tan G, Huguenard AL, Donovan KM, Demarest P, Liu X, Li Z, Adamek M, Lavine K, Vellimana AK, Kummer TT, Osbun JW, Zipfel GJ, Brunner P, Leuthardt EC. The effect of transcutaneous auricular vagus nerve stimulation on cardiovascular function in subarachnoid hemorrhage patients: A randomized trial. Elife. 2025 Jan 9;13:RP100088. doi: 10.7554/eLife.100088. | |
| 39178291 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Participants are assigned to either stimulation or sham stimulation arms
Not provided
Not provided
All participants will be fitted with an auricular stimulator, but blinded to whether they are receiving stimulation or not. Outcome scores and measures will be assessed and recorded by clinicians and research team members blinded to the treatment arm.
| Sham Auricular Vagus nerve Stimulation | Device | Transcutaneous auricular vagal nerve ear clip applied without current/stimulation |
|
Patient discharge destination (ie, home, acute rehab) |
| After hospital discharge, on average 14 days after admission. |
| Cost of ICU stay | Evaluation of total ICU cost of stay ($) | Through hospital admission, average 14 days |
| Cost of Hospital Admission | Evaluation of total hospital admission cost of stay ($) | Through hospital admission, average 14 days |
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. |
| 14 days |
| Cerebral Edema | Assessment of cerebral edema on each medically indicated and obtained head CT scan through assessment of selective sulcal volume (SSV) | 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). | 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). | 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). | 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). | 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). | Through hospital admission, average 14 days |
| Use of a ventilator | Quantification of days on ventilator | Through hospital admission, average 14 days |
| Huguenard A, Tan G, Johnson G, Adamek M, Coxon A, Kummer T, Osbun J, Vellimana A, Limbrick D Jr, Zipfel G, Brunner P, Leuthardt E. Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial. PLoS One. 2024 Aug 23;19(8):e0301154. doi: 10.1371/journal.pone.0301154. eCollection 2024. |
| 38746275 | Background | Huguenard AL, Tan G, Rivet DJ, Gao F, Johnson GW, Adamek M, Coxon AT, Kummer TT, Osbun JW, Vellimana AK, Limbrick DD, Zipfel GJ, Brunner P, Leuthardt EC. Auricular Vagus Nerve Stimulation Mitigates Inflammation and Vasospasm in Subarachnoid Hemorrhage: A Randomized Trial. medRxiv [Preprint]. 2024 May 1:2024.04.29.24306598. doi: 10.1101/2024.04.29.24306598. |