VNS Algorithm for Advanced Dosing

Epilepsies

Vagal Nerve Stimulation, Drug-Resistant Epilepsy

The goal of this clinical trial is to compare the standard programming of the VNS device (Control) to a modified programming (Augusta Way) in adults with epilepsy. The main question it aims to answer is: Does the modified programming of the VNS reduce seizures faster than the standard programming? Participants in both groups will: 1. Attend up to 3 study visits every 3 months for 2 years 2. Answer questionnaires to assess quality of life and cognitive function 3. Maintain a diary of seizure activity

Little has changed in the last 10 years or more in regard to Vagus nerve stimulator (VNS) therapy programming parameters despite new technological advances. The goal of our study is to provide a comprehensive VNS dosing protocol which VNS programmers can refer to as the standard care of treatment escalation in patients with drug refectory epilepsy. Given the lack of newly published data regarding VNS system parameters, this study will allow epileptologists, general neurologists and neurosurgeons alike, access to an updated reference and model of VNS parameter escalation and treatment. The investigators at Augusta University have developed a programming paradigm that appears to provide good clinical outcomes for VNS patients. The study will provide a comprehensive assessment of an experimental group ("the Augusta Way") programmed with a modified, more rapid titration paradigm developed at our site vs. "best clinical practice" (standard titration paradigm) control group of patients with VNS devices. The patients will be followed for at least 24 months post implantation. The study will assess safety of the new programming paradigm and will assess efficacy based upon seizure outcomes.

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United States