An interventional study of Auricular Vagus Nerve Stimulation and Sham Auricular Vagus nerve Stimulation in Intracerebral Hemorrhage, 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 2026-07-06.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following intracerebral hemorrhage.
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 inflammatory markers in the blood and cerebrospinal fluid (CSF) in patients with intracerebral hemorrhage, and how it impacts their clinical course and outcomes.
This study will involve randomizing patients to stimulation with VNS, or sham stimulation. Blood and CSF will be collected on admission, and serially throughout the patient's admission. Clinical events tracked during the hospital stay include the development of peri-hematomal edema, interventions for edema (medical or surgical), and intensive care unit and hospital stay. Outcomes following admission will include functional scores at discharge, and at follow-up visits for up to 2 years after discharge. No additional appointments will be made specially for the research study.
457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 269 interventional studies indexed under Cerebral Hemorrhage.
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Exclusion Criteria:
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
Change in the inflammatory marker IL-6 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
Growth of perihematomal edema
Change in edema extension distance (baseline vs. peak) will be compared between groups, via quantitative assessment of serial computed tomography (CT) scans obtained on day 1, 4, 7, 10, and 14 (Day 1 serves as baseline, prior to first treatment).
Time frame: 14 days
Neurological worsening
Occurrence of clinical deterioration due to edema by criteria of 1) a reduction in GCS by 2 points or greater that persists for at least one hour, 2) worsening focal neurological deficits (NIHSS increase by at least 4 points), excluding other causes, or 3) need for surgical intervention or medical treatments for edema (osmotic therapies).
Time frame: Through hospital admission, average 14 days
Change in additional inflammatory markers in plasma
Blood samples collected on days 1, 4, 7, 10, and 14 to evaluate for IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17a, GM-CSF, IFN gamma, and TNF-α. Inflammatory markers will be reported in pg/mL.
Time frame: 14 days
Change in inflammatory markers in cerebrospinal fluid
Cerebrospinal fluid samples collected on days 1, 4, 7, 10, and 14 to evaluate for IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17a, GM-CSF, IFN gamma, and TNF-α. Inflammatory markers will be reported in pg/mL.
Time frame: 14 days
Relative perihematomal edema
Relative perihematomal edema volume, the ratio of perihematoma volume to intracerebral hematoma volume
Time frame: 14 days
Neurological outcome
Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
Time frame: 2 years
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
Plan to share: No
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