Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry
Icahn School of Medicine at Mount Sinai
40 participants
Oct 9, 2024
OBSERVATIONAL
Conditions
Summary
Vagal Nerve Stimulation is a novel proven therapy for patients with chronic ischemic stroke. The primary objective of this registry is to assess the safety of vagal nerve stimulation for stroke recovery through monitoring the occurrence of serious adverse events associated with the surgical procedure or subsequent paired rehabilitation protocol. This registry will monitor patients undergoing VNS for stroke recovery in the Mount Sinai Health System and collect clinical and procedural details, objective outcomes, and patient-reported outcomes associated with vagal nerve stimulation for stroke recovery.
Eligibility
Inclusion Criteria6
- Provision of signed and dated informed consent form
- Stated willingness to comply with all procedures in the VNS-Enhanced Stroke Recovery Program
- Aged 18 or older
- History of ischemic stroke
- Upper extremity weakness
- Planned to undergo VNS implantation
Exclusion Criteria2
- Unfavorable candidacy for device implant surgery (e.g., history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, prior injury to the vagus nerve etc.).
- Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from meeting protocol timeline.
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05694663