100
Participants
Start Date
November 1, 2022
Primary Completion Date
December 31, 2028
Study Completion Date
December 31, 2028
Vivistim
After one month of prehabiliatory training, the patient will then undergo surgical placement of the implantable VNS device (Vivistim System) consisting of an implantable neurostimulator and an implantable lead and electrode per standard of care. The device comes with a controller and software system which allows for control of the stimulation settings during the rehabilitation phase. The PMA number for this device is 210007 and the date of FDA notice of approval occurred on August 27, 2021.
RECRUITING
Icahn School of Medicine at Mount Sinai, New York
Icahn School of Medicine at Mount Sinai
OTHER