Auricular VNS Following Intracerebral Hemorrhage

July 14, 2025 updated by: Washington University School of Medicine

Vagus Nerve Stimulation Following Intracerebral Hemorrhage (IHC) to Mitigate ICH-induced Inflammation and Cerebral Edema

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eric Leuthardt, MD MBA
        • Sub-Investigator:
          • Raj Dhar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auricular VNS Stimulation
Participants receive twice daily auricular vagal nerve stimulation
Device: Auricular Vagus Nerve Stimulation
Transcutaneous auricular vagal nerve stimulation
Sham Comparator: Sham Auricular VNS Stimulation
Participants will have an auricular vagal nerve stimulator placed in their ear twice daily, without the stimulation applied
Device: Sham Auricular Vagus nerve Stimulation
Transcutaneous auricular vagal nerve ear clip applied without current

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the inflammatory marker IL-6 in plasma
Time Frame: 14 days
Blood samples collected on days 1, 4, 7, 10, and 14 (Day 1 serves as baseline, prior to first treatment). Inflammatory markers will be reported in pg/mL.
14 days
Growth of perihematomal edema
Time Frame: 14 days
Change in edema extension distance (baseline vs. peak) will be compared between groups, via quantitative assessment of serial computed tomography (CT) scans obtained on day 1, 4, 7, 10, and 14 (Day 1 serves as baseline, prior to first treatment).
14 days
Neurological worsening
Time Frame: Through hospital admission, average 14 days
Occurrence of clinical deterioration due to edema by criteria of 1) a reduction in GCS by 2 points or greater that persists for at least one hour, 2) worsening focal neurological deficits (NIHSS increase by at least 4 points), excluding other causes, or 3) need for surgical intervention or medical treatments for edema (osmotic therapies).
Through hospital admission, average 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in additional inflammatory markers in plasma
Time Frame: 14 days
Blood samples collected on days 1, 4, 7, 10, and 14 to evaluate for IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17a, GM-CSF, IFN gamma, and TNF-α. Inflammatory markers will be reported in pg/mL.
14 days
Change in inflammatory markers in cerebrospinal fluid
Time Frame: 14 days
Cerebrospinal fluid samples collected on days 1, 4, 7, 10, and 14 to evaluate for IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IL-17a, GM-CSF, IFN gamma, and TNF-α. Inflammatory markers will be reported in pg/mL.
14 days
Relative perihematomal edema
Time Frame: 14 days
Relative perihematomal edema volume, the ratio of perihematoma volume to intracerebral hematoma volume
14 days
Neurological outcome
Time Frame: 2 years
Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)
2 years
Hospital length of stay
Time Frame: Through hospital admission, average 14 days
Total length of stay in the hospital, and in the intensive care unit
Through hospital admission, average 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Study Chair: Eric Leuthardt, MD MBA, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2025

Primary Completion (Estimated)

February 9, 2030

Study Completion (Estimated)

February 9, 2032

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

January 29, 2025

Study Record Updates

Last Update Posted (Actual)

July 15, 2025

Last Update Submitted That Met QC Criteria

July 14, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202408166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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