Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct (NUVISTA)
Acute Ischemic Stroke
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring acute ischemic stroke, cytokines, large vessel occlusion, vagal nerve stimulator
Eligibility 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.
Sites / Locations
- Washington University in St. Louis School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Stimulation with Transcutaneous Auricular Vagal Nerve Stimulator
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, 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.
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.