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Intracerebral HemorrhageNCT06799390

Auricular VNS Following Intracerebral Hemorrhage

A study testing Auricular Vagus Nerve Stimulation in people with Intracerebral Hemorrhage, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
Auricular Vagus Nerve Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteUnited States
Study dates
6 Apr 2025to 9 Feb 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients who present with a spontaneous supratentorial intracerebral hemorrhage (ICH) to Barnes Jewish Hospital

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Raj Dhar, MD contact

314-362 2999

dharr@wustl.edu

United States1 site, 1 recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Juliana Amaral Passipieri, PhD, 314-747-1443, ajuliana@wustl.edu

    Elma Heric, BS, 314-362-3570, elmah@wustl.edu

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Auricular Vagus Nerve Stimulation, Sham Auricular Vagus nerve Stimulation
Keywords
vagal nerve stimulation, pathologic processes, intracerebral hemmorrhage, cerebrovascular disorders, brain diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Hemorrhage
Medical subject headings
Cerebral Hemorrhage, Pathologic Processes, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Auricular Vagus Nerve StimulationDevice

    Transcutaneous auricular vagal nerve stimulation

  • Sham Auricular Vagus nerve StimulationDevice

    Transcutaneous auricular vagal nerve ear clip applied without current

Study groups in NCT06799390
Study groupRoleWhat they receive
Auricular VNS StimulationExperimentalParticipants receive twice daily auricular vagal nerve stimulation
Receives: Device: Auricular Vagus Nerve Stimulation
Sham Auricular VNS StimulationSham comparatorParticipants will have an auricular vagal nerve stimulator placed in their ear twice daily, without the stimulation applied
Receives: Device: Sham Auricular Vagus nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the inflammatory marker IL-6 in plasma

    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.

    Measured: 14 days

  2. Growth of perihematomal edema

    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).

    Measured: 14 days

  3. Neurological worsening

    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).

    Measured: Through hospital admission, average 14 days

Secondary outcomes (5)

  1. Change in additional inflammatory markers in plasma

    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.

    Measured: 14 days

  2. Change in inflammatory markers in cerebrospinal fluid

    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.

    Measured: 14 days

  3. Relative perihematomal edema

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

    Measured: 14 days

  4. Neurological outcome

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

    Measured: 2 years

  5. Hospital length of stay

    Total length of stay in the hospital, and in the intensive care unit

    Measured: Through hospital admission, average 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2025
  2. Study start6 Apr 2025
  3. Primary completion9 Feb 2030 (estimated)
  4. Study completion9 Feb 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are assigned to either stimulation or sham stimulation arms
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06799390
Sponsor's protocol ID
202408166
Status last verified
Jul 2026
First submitted
13 Jan 2025
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Huguenard AL, Tan G, Rivet DJ, Gao F, Johnson GW, Adamek M, Coxon AT, Kummer TT, Osbun JW, Vellimana AK, Limbrick DD, Zipfel GJ, Brunner P, Leuthardt EC. Auricular Vagus Nerve Stimulation Mitigates Inflammation and Vasospasm in Subarachnoid Hemorrhage: A Randomized Trial. medRxiv [Preprint]. 2024 May 1:2024.04.29.24306598. doi: 10.1101/2024.04.29.24306598.

    PubMed 38746275

  • Huguenard A, Tan G, Johnson G, Adamek M, Coxon A, Kummer T, Osbun J, Vellimana A, Limbrick D Jr, Zipfel G, Brunner P, Leuthardt E. Non-invasive Auricular Vagus nerve stimulation for Subarachnoid Hemorrhage (NAVSaH): Protocol for a prospective, triple-blinded, randomized controlled trial. PLoS One. 2024 Aug 23;19(8):e0301154. doi: 10.1371/journal.pone.0301154. eCollection 2024.

    PubMed 39178291

  • Tan G, Huguenard AL, Donovan KM, Demarest P, Liu X, Li Z, Adamek M, Lavine K, Vellimana AK, Kummer TT, Osbun JW, Zipfel GJ, Brunner P, Leuthardt EC. The effect of transcutaneous auricular vagus nerve stimulation on cardiovascular function in subarachnoid hemorrhage patients: A randomized trial. Elife. 2025 Jan 9;13:RP100088. doi: 10.7554/eLife.100088.

    PubMed 39786346

Questions about this trial

What is this clinical trial studying?

A study testing Auricular Vagus Nerve Stimulation in people with Intracerebral Hemorrhage, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Raj Dhar, MD (314-362 2999, dharr@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the inflammatory marker IL-6 in plasma (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06799390, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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