Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct 2
Washington University School of Medicine
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.
Description
Ischemic stroke is a leading cause of death and long-term disability worldwide. Large vessel occlusion (LVO) accounts for \~38% of acute ischemic strokes (AIS) and is associated with disproportionately poor outcomes: without treatment, 64% of patients are dead or dependent at six months, and even after successful mechanical thrombectomy, nearly half have poor functional recovery. These data highlight a critical unmet need for adjunctive therapies that limit secondary brain injury following reperfusion. Neuroinflammation is a major contributor to ischemic brain injury and neurologic deteriorat…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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.
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.
Location
- Barnes-Jewish HospitalSt Louis, Missouri