Registry Study of Vivistim Vagal Nerve Stimulation Device for Recovery After Chronic Ischemic Stroke

What this Trial Is About

Researchers are evaluating vagal nerve stimulation VNS as a therapy for patients recovering from chronic ischemic stroke. This observational registry study aims to assess the safety of VNS by tracking serious adverse events related to the surgical implantation and the paired rehabilitation protocol. The trial also explores the feasibility and effectiveness of VNS for stroke recovery and collects patient-reported experiences during rehabilitation. Participants will undergo surgical implantation of the Vivistim VNS device after one month of preparatory training. The device includes an implantable neurostimulator, lead, and electrode, controlled by software to adjust stimulation during rehabilitation. This registry monitors patients receiving VNS as part of their standard care within the Mount Sinai Health System. During the study, participants will be assessed using various clinical and functional tests over a period up to 390 days, including the Fugl Meyer Assessment for upper and lower extremities, Wolf Motor Function Test, Action Research Arm Test, and cognitive and depression scales. Researchers will collect clinical, procedural, and patient-reported data to understand the impact of VNS on stroke recovery while monitoring safety and treatment feasibility.

Vagal Nerve Stimulation in Enhanced Stroke Recovery: The VALOR Registry