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)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06799390


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