Auricular VNS Following Intracerebral Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-06

Study Completion Date

2032-02-09

Brief Summary

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

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Detailed Description

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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.

Conditions

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Intracerebral Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to either stimulation or sham stimulation arms

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

All participants will be fitted with an auricular stimulator, but blinded to whether they are receiving stimulation or not. Outcome scores will be assessed and recorded by clinicians blinded to treatment arm.

Study Groups

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Auricular VNS Stimulation

Participants receive twice daily auricular vagal nerve stimulation

Group Type EXPERIMENTAL

Auricular Vagus Nerve Stimulation

Intervention Type DEVICE

Transcutaneous auricular vagal nerve stimulation

Sham Auricular VNS Stimulation

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

Group Type SHAM_COMPARATOR

Sham Auricular Vagus nerve Stimulation

Intervention Type DEVICE

Transcutaneous auricular vagal nerve ear clip applied without current

Interventions

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Auricular Vagus Nerve Stimulation

Transcutaneous auricular vagal nerve stimulation

Intervention Type DEVICE

Sham Auricular Vagus nerve Stimulation

Transcutaneous auricular vagal nerve ear clip applied without current

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No