Transcutaneous Auricular Vagus Enhanced Recovery in the NeuroICU

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07219108
Status
Recruiting
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Conditions

  • Acute Medical Conditions
  • Acute Neurological Injury

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/stimulation

Study Details

This study will demonstrate the impact of taVNS on reducing adverse events in NeuroICU patients, determine if taVNS reduces length of stay, and quantify the economic benefits of taVNS implementation in a broader neurocritical care population.

Key Dates

Start date
Sep 24, 2025
Status verified
Oct 2025
Primary completion
Sep 23, 2027
Completion
Sep 23, 2027

Study Design

Enrollment
160 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

Assessment of the need for tracheostomy. [ Time Frame: 14 days ]

Central Contacts

Locations (1)

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

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