Auricular VNS Following Intracerebral Hemorrhage

The Washington University

Status: Enrolling

Conditions: Intracerebral Hemorrhage

Treatments: Device: Auricular Vagus Nerve Stimulation; Device: Sham Auricular Vagus nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06799390

202408166

Details and patient eligibility

About

This study will evaluate whether non-invasive auricular vagal nerve stimulation lowers inflammatory markers, and improves outcomes following intracerebral hemorrhage.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Auricular VNS Stimulation

Experimental group

Description:

Participants receive twice daily auricular vagal nerve stimulation

Treatment:

Device: Auricular Vagus Nerve Stimulation

Sham Auricular VNS Stimulation

Sham Comparator group

Description:

Participants will have an auricular vagal nerve stimulator placed in their ear twice daily, without the stimulation applied

Treatment:

Device: Sham Auricular Vagus nerve Stimulation