Auricular VNS Following Intracerebral Hemorrhage

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06799390
Status
Recruiting

Conditions

  • Intracerebral Hemorrhage

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
Apr 6, 2025
Status verified
Jul 2025
Primary completion
Feb 9, 2030
Completion
Feb 9, 2032

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Change in the inflammatory marker IL-6 in plasma [ Time Frame: 14 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Juliana Amaral Passipieri, PhD
314-747-1443
Elma Heric, BS
314-362-3570
Eric Leuthardt, MD MBA (PRINCIPAL_INVESTIGATOR)
Raj Dhar, MD (SUB_INVESTIGATOR)

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