Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

Patients Undergoing Vagal Nerve Stimulation for Stroke Recovery

Individuals undergoing vagal nerve stimulation (VNS) paired rehabilitation will be included in this cohort.
This is a registry study with no active intervention outside standard of care. Patients with chronic ischemic stroke will be implanted with the Vivistim vagal nerve stimulation device per standard of care.

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.
Other Name: Standard of Care

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

January 24, 2023Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
Comments