VNS Algorithm for Advanced Dosing
ConditionEpilepsies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFernando Vale
About this trial
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
Eligibility criteria
Qualifiers
Subjects who are clinically determined to be candidates for VNS implantation for seizure control
Subject/legally authorized representative able to provide informed consent.
Disqualifiers
Subjects with VNS system treating pathologies other than drug refractory epilepsy or medical co-morbidities that prevent any surgical intervention
Trial design
Treatments tested in this trial
- Rapid Titration VNS programming
- Standard VNS programming
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov