RecruitingNot ApplicableNCT06799390
Auricular VNS Following Intracerebral Hemorrhage
Vagus Nerve Stimulation Following Intracerebral Hemorrhage (IHC) to Mitigate ICH-induced Inflammation and Cerebral Edema
Sponsor
Washington University School of Medicine
Enrollment
80 participants
Start Date
Apr 6, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following intracerebral hemorrhage.
Eligibility
Min Age: 18 Years
Inclusion Criteria1
- Adult patients who present with a spontaneous supratentorial intracerebral hemorrhage (ICH) to Barnes Jewish Hospital
Exclusion Criteria5
- 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.
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Interventions
DEVICEAuricular Vagus Nerve Stimulation
Transcutaneous auricular vagal nerve stimulation
DEVICESham Auricular Vagus nerve Stimulation
Transcutaneous auricular vagal nerve ear clip applied without current
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06799390
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