Recruiting

Auricular VNS

Sponsor:

Washington University School of Medicine

Code:

NCT06799390

Conditions

Intracerebral Hemorrhage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Auricular Vagus Nerve Stimulation

Sham Auricular Vagus nerve Stimulation

Study Details

Brief summary:

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

Conditions

Intracerebral Hemorrhage

Study ID

NCT06799390

Start date

Apr 6, 2025

Status verified date

Jul, 2026

Completion date

Feb 9, 2032

Anticipated

Primary completion date

Feb 9, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Auricular VNS Stimulation

Participants receive twice daily 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

Interventions

Auricular Vagus Nerve Stimulation

Transcutaneous auricular vagal nerve stimulation

Sham Auricular Vagus nerve Stimulation

Transcutaneous auricular vagal nerve ear clip applied without current

Primary outcome measure

  • Change in the inflammatory marker IL-6 in plasma [ Time Frame: 14 days ]
  • Growth of perihematomal edema [ Time Frame: 14 days ]
  • Neurological worsening [ Time Frame: Through hospital admission, average 14 days ]

Central Contacts and Locations

Central contacts

Raj Dhar, MD

314-362 2999dharr@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Juliana Amaral Passipieri, PhD

314-747-1443ajuliana@wustl.edu

Elma Heric, BS

314-362-3570elmah@wustl.edu

Principal Investigator:

Eric Leuthardt, MD MBA

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • vagal nerve stimulation
  • pathologic processes
  • intracerebral hemmorrhage
  • cerebrovascular disorders
  • brain diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Vascular Diseases
  • Hemorrhage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-06.