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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
iVEAcare Neuromodulation System implant
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
RECRUITINGThe Mater
South Brisbane, Queensland, Australia
RECRUITINGMonash Health
Clayton, Victoria, Australia
RECRUITINGSt. Vincent's Hospital
Fitzroy, Victoria, Australia
RECRUITINGAustin Hospital
Heidelberg, Victoria, Australia
RECRUITINGThe Alfred Hospital
Melbourne, Victoria, Australia
RECRUITINGMelbourne Health
Parkville, Victoria, Australia
RECRUITINGiVEAcare Neuromodulation System Safety
assessment of the rate of serious treatment-related (procedure, device- and/or therapy-related) adverse events
Time frame: 30 days
Seizure Frequency
Change from baseline in frequency of daily seizures, averaged over the 90 days prior to the visit
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 6 months
Clinician View of Overall Status
Clinical Global Impression - Improvement (CGI-I) compared to baseline. CGI-I is a single question where the physician indicates the participant's status compared to baseline with 5 options ranging from Much Better to Much Worse.
Time frame: 6 months
Depression
Change from baseline in the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) on a scale from 6-24, where lower scores are considered less depression.
Time frame: 6 months
Anti-seizure Medication Use
Change from baseline in anti-seizure medications
Time frame: 6 months
IPG Replacement Assessment
The number of cases where the existing implanted lead works as intended with the IVEAcare IPG
Time frame: At implant
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