Using auricular vagus nerve stimulation to improve outcomes after brain bleeding
Vagus Nerve Stimulation Following Intracerebral Hemorrhage (IHC) to Mitigate ICH-induced Inflammation and Cerebral Edema
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT06799390 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult patients presenting with spontaneous supratentorial intracerebral hemorrhage at Barnes Jewish Hospital.
Not a fit: Patients under 18 years old, those with traumatic intracerebral hemorrhage, or those with severe comorbidities may not benefit from this study.
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 performed: Previous studies have shown promise for vagal nerve stimulation in reducing inflammation in animal models, but this specific application in humans is novel.
Eligibility criteria
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 this trial is running
St Louis, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.