Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

RecruitingOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

November 1, 2022

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Chronic Ischemic Stroke
Interventions
DEVICE

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.

Trial Locations (1)

10128

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

All Listed Sponsors
lead

Icahn School of Medicine at Mount Sinai

OTHER