An interventional study of Rapid Titration VNS programming and Standard VNS programming in Epilepsies, sponsored by Fernando Vale. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Fernando Vale · Not applicable, Interventional, and Treatment
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:
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 80 is above the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →This is the only study on the registry with Fernando Vale as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Modified programming of VNS that provides rapid titration
Device: Rapid Titration VNS programming
Standard of care VNS programming
Device: Standard VNS programming
Modified programming of VNS that provides rapid titration
Standard of Care VNS programming
Seizure Diary
A seizure diary is a personalized log used to record seizure activity, medication adherence, and potential triggers
Time frame: From enrollment to end of participation at 2 years
Plan to share: No
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