Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct 2
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• Adult patients who present with acute ischemic strokes due to large vessel occlusions
Locations
United States
Missouri
Barnes-Jewish Hospital
RECRUITING
St Louis
Contact Information
Primary
Angela Birke, MS
birkea@wustl.edu
(314) 362-5291
Backup
Osvaldo Laurido-Soto, MD
ojlaurido-soto@wustl.edu
314-273-3294
Time Frame
Start Date: 2026-02-23
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 65
Treatments
Experimental: Treatment - Stimulation with Transcutaneous Auricular Vagal Nerve Stimulator
All patients will be fitted with the device, the investigator will attach an electrode 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.
Sham_comparator: Control - No Stimulation Transcutaneous Auricular Vagal Nerve Stimulator
All patients will be fitted with the device, the investigator will attach an electrode to the left ear. Sham stimulation sessions will occur for 20 minutes twice daily during the inpatient period. Patients assigned to the controls arm will have no electricity applied to the auricular branch of the vagus nerve.
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine