RecruitingNot ApplicableNCT07404852

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

Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct 2


Sponsor

Washington University School of Medicine

Enrollment

65 participants

Start Date

Feb 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria1

  • Adult patients who present with acute ischemic strokes due to large vessel occlusions

Exclusion Criteria9

  • \<18 years old
  • patients with presumed chronic large vessel occlusions
  • NIHSS\<6
  • pre-morbid modified Rankin score (mRS) \>2
  • unable to initiate treatment under 24 hours from symptom discovery
  • Chronic or acute infection, Recent surgery, active immune disease
  • life expectancy \<3 months
  • patients' undergoing active cancer or immunosuppressive/modulating therapy
  • patients with sustained bradycardia on arrival with a heart rate \<50 beats per minute.

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Interventions

DEVICEtranscutaneous auricular vagal nerve stimulation

Stimulus of the auricular branch of the vagal nerve with the transcutaneous auricular vagal nerve stimulation.

DEVICESham transcutaneous vagal nerve stimulation

Patients assigned to the controls arm will have no electricity applied to the Auricular Branch of the Vagus Nerve.


Locations(1)

Barnes-Jewish Hospital

St Louis, Missouri, United States

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NCT07404852


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