Using vagus nerve stimulation to improve outcomes after ischemic stroke
Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct
NA · Washington University School of Medicine · NCT05390580
This study is testing if adding vagus nerve stimulation to standard treatment can help people recover better after a stroke caused by a blocked blood vessel.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine (other) |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT05390580 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effects of transcutaneous auricular vagal nerve stimulation in patients with acute ischemic strokes caused by large vessel occlusions. Participants will be randomly assigned to receive either standard treatment or standard treatment plus vagal nerve stimulation. The study aims to assess inflammatory laboratory values and explore clinical outcomes to determine if this adjunct therapy can improve recovery. The focus is on addressing neuroinflammation, which is a significant factor in stroke pathology and recovery.
Who should consider this trial
Good fit: Ideal candidates are adult patients presenting with acute ischemic strokes due to large vessel occlusions.
Not a fit: Patients under 18 years old or those with chronic large vessel occlusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and reduced disability for patients following an ischemic stroke.
How similar studies have performed: While there is ongoing research into anti-inflammatory interventions for acute ischemic stroke, this specific approach using vagus nerve stimulation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients who present with acute ischemic strokes due to large vessel occlusions Exclusion Criteria: * \<18 years old * patients with presumed chronic large vessel occlusions * NIHSS\<6 * pre-morbid modified Rankin score (mRS) \>2 * unable to initiate treatment under 36 hours from symptom discovery * Chronic or severe infection * 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.
Where this trial is running
Saint Louis, Missouri
- Washington University in St. Louis School of Medicine — Saint Louis, Missouri, United States (RECRUITING)
Study contacts
- Study coordinator: Osvaldo J Laurido-Soto, MD
- Email: ojlaurido-soto@wustl.edu
- Phone: 314-273-3294
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Ischemic Stroke, acute ischemic stroke, cytokines, large vessel occlusion, vagal nerve stimulator