Non-invasive vagus nerve stimulation to lower inflammation and brain injury markers after acute ischemic stroke
Official title: Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct 2
Run by Washington University School of Medicine · NCT07404852 · Data updated 2026-11-12
This test tries whether adding non-invasive vagus nerve stimulation to usual care lowers inflammation and blood markers of brain injury in adults with acute ischemic stroke from a large vessel occlusion.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 65 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | February 23, 2026 |
| Main results expected | November 29, 2027 |
| Study ends | February 29, 2028 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07404852 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults presenting with acute ischemic stroke from a large vessel occlusion, with NIHSS ≥6, pre-stroke mRS ≤2, able to start treatment within 24 hours, and without active infection, recent surgery, immunosuppression, or severe bradycardia.
✕Probably not a fit
Patients unlikely to benefit include those with chronic large vessel occlusions, NIHSS <6, pre-morbid disability (mRS >2), active or recent infection/surgery, ongoing immunosuppressive cancer therapy, life expectancy under three months, or sustained bradycardia (HR <50).
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, open-label pilot comparing usual care alone versus usual care plus transcutaneous auricular vagus nerve stimulation (taVNS) in adults with acute ischemic stroke due to large vessel occlusion. Outcomes include changes in inflammatory cytokines and blood biomarkers of brain injury, with blinded assessment of key clinical endpoints. Enrollment targets patients who can start treatment within 24 hours of symptom discovery and who meet standard neurologic and medical inclusion criteria. The design is intended to detect biological signal and explore whether taVNS could be a feasible adjunct to reperfusion therapies.
Why it matters
Potential benefit: If successful, adding non-invasive VNS could reduce secondary inflammatory brain injury after reperfusion and improve recovery by lowering harmful biomarkers.
How similar studies have gone: Small pilot work including the NUVISTA randomized pilot (n=35) has tested VNS in this setting but evidence so far is preliminary and not definitive.
Who can join: the full rules
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 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.
Where it's running
-
Barnes-Jewish Hospital
St Louis, Missouri, United States Recruiting
Study contacts
- Study coordinator: Angela Birke, MS
- Email: birkea@wustl.edu
- Phone: (314) 362-5291
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.