VNS Algorithm for Advanced Dosing: Example Guided Mode Titrations "The Augusta Way"
Fernando Vale
Summary
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
Description
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 inv…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subjects who are clinically determined to be candidates for VNS implantation for seizure control * Subject/legally authorized representative able to provide informed consent. Exclusion Criteria: * Subjects with VNS system treating pathologies other than drug refractory epilepsy or medical co-morbidities that prevent any surgical intervention
Interventions
- DeviceRapid Titration VNS programming
Modified programming of VNS that provides rapid titration
- DeviceStandard VNS programming
Standard of Care VNS programming
Location
- Wellstar MCG HospitalAugusta, Georgia