Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05390580
Status
Completed

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. Stimulus will be provided to the lobule of the ear, which is not innervated by 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 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
Sep 26, 2022
Status verified
Oct 2025
Primary completion
Aug 23, 2024
Completion
Aug 23, 2024

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stimulation with Transcutaneous Auricular Vagal Nerve Stimulator
    All patients will be fitted with the device, the investigator will attach adhesive contacts 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. The amplitude of stimulation may be reduced if a patient complains of discomfort at the site of stimulation.
  • Sham Comparator: Control - Transcutaneous Auricular Vagal Nerve Stimulator - Sham
    All patients will be fitted with the device, the investigator will attach adhesive contacts to the left ear. Stimulation sessions will occur for 20 minutes twice daily during the inpatient period. Patients assigned to the controls arm will have electricity applied to the the great auricular nerve (cervical nerve branch), the lobule of the ear. The investigator will stimulate the lobule of the ear. Patients' will be treated with the following parameters: frequency 20 Hz, pulse width 250 µm, and and a fixed intensity of 0.5 milliampere. The amplitude of stimulation may be reduced if a patient complains of discomfort at the site of stimulation.

Primary Outcome Measure

Interleukin - 1b - Changes and Differences in the Levels [ Time Frame: 5 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University in St. Louis School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Washington University in St. Louis School of Medicine· St Louis, MO

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