VNS Algorithm for Advanced Dosing
Recruiting · NCT07725601 · Interventional (participants receive a specific treatment) · Lead sponsor: Fernando Vale
View the official record on ClinicalTrials.gov →Interventions studied
Rapid Titration VNS programmingStandard VNS programming
What this trial is about
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
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Wellstar MCG Hospital - Augusta, Georgia, United States