Non-invasive Vagus Nerve Stimulation to Reduce Inflammation and Brain Injury Blood Biomarkers Following an Acute Ischemic Stroke

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07404852
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • transcutaneous auricular vagal nerve stimulation — DEVICE
    Stimulus of the auricular branch of the vagal nerve with the transcutaneous auricular vagal nerve stimulation.
  • Sham transcutaneous vagal nerve stimulation — DEVICE
    Patients assigned to the controls arm will have no electricity applied to the Auricular Branch of the Vagus Nerve.

Study Details

This is a randomized open-label, with blinded outcome pilot study to evaluate the effect on inflammatory and brain injury laboratory values and explore clinical outcomes in patients who present with ischemic strokes due to large vessel occlusions and are treated with either current accepted management, or accepted management in addition to transcutaneous auricular vagal nerve stimulation.

Key Dates

Start date
Feb 23, 2026
Status verified
Feb 2026
Primary completion
Nov 29, 2027
Completion
Feb 29, 2028

Study Design

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

Arms

  • Experimental: Treatment - Stimulation with Transcutaneous Auricular Vagal Nerve Stimulator
    All patients will be fitted with the device, the investigator will attach an electrode to the left ear. Stimulation sessions will occur for 20 minutes twice daily during the inpatient period, the investigator will stimulate the auricular branch of the vagus nerve. Patients' will be treated with the following parameters: frequency 20 Hz, pulse width 250 μm, and and a fixed intensity of 0.5 milliampere.
  • Sham Comparator: Control - No Stimulation Transcutaneous Auricular Vagal Nerve Stimulator
    All patients will be fitted with the device, the investigator will attach an electrode to the left ear. Sham stimulation sessions will occur for 20 minutes twice daily during the inpatient period. Patients assigned to the controls arm will have no electricity applied to the auricular branch of the vagus nerve.

Primary Outcome Measure

Brain Derived Tau [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Barnes-Jewish HospitalSt LouisMissouri63110
Angela Birke, MS
[email protected]
(314) 362-5291
Osvaldo J Laurido-Soto, MD
[email protected]
Osvaldo J Laurido-Soto, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Barnes-Jewish Hospital· St Louis, MO

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