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Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry

NCT05694663 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2026-05-08

No results posted yet for this study

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Christopher P Kellner, MD · Icahn School of Medicine at Mount Sinai

  • David Putrino, PT, PhD · Icahn School of Medicine at Mount Sinai

  • Fedor Panov, MD · Icahn School of Medicine at Mount Sinai

  • Jenna Tosto, PT, DPT, NCS · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-09
Primary Completion
2028-02-29
Completion
2028-02-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05694663 on ClinicalTrials.gov