Using auricular vagus nerve stimulation to improve outcomes after brain bleeding
Official title: Vagus Nerve Stimulation Following Intracerebral Hemorrhage (IHC) to Mitigate ICH-induced Inflammation and Cerebral Edema
Run by Washington University School of Medicine · NCT06799390 · Data updated 2026-11-12
This study is testing if a new type of ear stimulation can help people recover better and have fewer complications after bleeding in the brain.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | April 6, 2025 |
| Main results expected | February 9, 2030 |
| Study ends | February 9, 2032 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT06799390 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult patients presenting with spontaneous supratentorial intracerebral hemorrhage at Barnes Jewish Hospital.
✕Probably not a fit
Patients under 18 years old, those with traumatic intracerebral hemorrhage, or those with severe comorbidities may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effects of non-invasive auricular vagal nerve stimulation (VNS) on inflammatory markers and clinical outcomes in patients who have experienced an intracerebral hemorrhage. Participants will be randomly assigned to receive either active VNS or sham stimulation, with blood and cerebrospinal fluid samples collected to assess inflammation. Clinical events, such as the development of edema and length of hospital stay, will be monitored, along with functional outcomes at discharge and follow-up visits for up to two years. The goal is to determine if VNS can improve recovery and reduce complications following this serious condition.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and reduced complications for patients after an intracerebral hemorrhage.
How similar studies have gone: Previous studies have shown promise for vagal nerve stimulation in reducing inflammation in animal models, but this specific application in humans is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients who present with a spontaneous supratentorial intracerebral hemorrhage (ICH) to Barnes Jewish Hospital Exclusion Criteria: * Patients \< 18 years old * Patients with a presumed traumatic etiology for their ICH, infratentorial location, ICH volume \> 60 ml or \< 10 ml, at risk of imminent death (e.g. Glasgow Coma Scale, GCS of 3 or one or more pupils unreactive), surgical intervention imminently planned (not including ventriculostomy) * Patients undergoing active cancer therapy * Patients with sustained bradycardia on arrival with a heart rate \< 50 beats per minute. * Patients who cannot be enrolled within 48 hours of the initial bleed.
Where it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.