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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Rapid Titration VNS programming
DeviceModified programming of VNS that provides rapid titration
Standard VNS programming
DeviceStandard of Care VNS programming
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Augusta WayExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov