Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct
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 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
Washington University in St. Louis School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Osvaldo J Laurido-Soto, MD
ojlaurido-soto@wustl.edu
314-273-3294
Backup
Angela Birke
birkea@wustl.edu
(314) 362-5291
Time Frame
Start Date: 2022-09-26
Estimated Completion Date: 2024-12-23
Participants
Target number of participants: 80
Treatments
Experimental: Stimulation with Transcutaneous Auricular Vagal Nerve Stimulator
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.
Sham_comparator: 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. 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.
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine