The purpose of this study is to assess the safety and performance of the iVEAcare Neuromodulation System for the treatment of drug-resistant epilepsy.
The main questions it aims to answer are:
What medical problems do participants have when being implanted with and using the iVEAcare system? Does the iVEAcare neurostimulator reduce seizure frequency and severity in patients with drug-resistant epilepsy? Does the iVEAcare neurostimulator improve quality of life in patients with drug-resistant epilepsy?
All participants will be implanted with an iVEAcare neurostimulator, and researchers will look at whether any medical problems are caused by the implant procedure or device, and how stimulation changes seizure frequency and severity and participant quality of life compared to when the participant enrolled.
Participants will:
Be implanted with an iVEAcare device. Visit the clinic 1-month, 3-months, 6-months, 1-year, 18-months and then annually through 5 years where they will be asked to answer questionnaires about their seizures and quality of life.
Keep a diary of the number of seizures they have each day.
Age 4 to 75 years.
Focal (partial) onset seizures (with or without secondary generalization) or generalized seizures that are refractory to anti-seizure medications.
A minimum of 4 seizures per month averaged over the 90 days prior to enrollment.
Participant is diagnosed with Drug Resistant Epilepsy (DRE) - Failure to achieve seizure control with adequate trials of two or more tolerated anti-seizure medications.
Unsuitable for iVEAcare Neuromodulation System implant surgery.
Deteriorating neurologic or other deteriorating medical conditions.
Previous left vagotomy (left vagus nerve cut to treat another disorder).
A condition currently requiring diathermy treatment anywhere in their body (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy).
Single group
iVEAcare Neuromodulation System
DeviceiVEAcare Neuromodulation System implant
iVEAcare Neuromodulation System Safety
assessment of the rate of serious treatment-related (procedure, device- and/or therapy-related) adverse events
Seizure Frequency
Change from baseline in frequency of daily seizures, averaged over the 90 days prior to the visit
Seizure Severity
Change from baseline in the Seizure Severity Questionnaire (SSQ) Score, which measures seizure intensity and duration on a scale of 1-7 where lower scores indicate lower seizure severity.
Change in Quality of Life
Change from baseline in Quality of Life as measured by the Quality of Life in Epilepsy (QOLIE-31) Questionnaire on a scale from 0-100, where higher scores are considered better quality of life.
Participant View of Overall Status
Subject Global Impression of Change (SGIC) compared to baseline. SGIC is a single question where the participant indicates their status compared to baseline with 7 options ranging from Very Much Improved to Very Much Worse.
