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NCT Number: NCT06799390

Auricular VNS Following Intracerebral Hemorrhage

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Elma Heric, BS

CONTACT

[email protected]

314-362-3570

Eric Leuthardt, MD MBA

PRINCIPAL_INVESTIGATOR

Juliana Amaral Passipieri, PhD

CONTACT

[email protected]

314-747-1443

Raj Dhar, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Auricular vagus nerve stimulation

Device

Transcutaneous auricular vagal nerve stimulation

Sham Auricular vagus nerve stimulation

Device

Transcutaneous auricular vagal nerve ear clip applied without current

Primary outcomes

  1. 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.

  2. 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).

  3. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. Relative perihematomal edema

    Time frame: 14 days

    Relative perihematomal edema volume, the ratio of perihematoma volume to intracerebral hematoma volume

  4. Neurological outcome

    Time frame: 2 years

    Modified Rankin Scale for Neurological Disability (minimum score 0, maximum score 6, better outcomes have lower scores)

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Raj Dhar, MD

CONTACT

[email protected]

314-362 2999

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Jan 29, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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