Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: iVEAcare Neuromodulation System.
- Who it may be relevant to
- Registry conditions: Drug Resistant Epilepsy. Basic parameters: 4 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device iVEAcare Neuromodulation System
iVEAcare Neuromodulation System implant
Primary outcome measures
- iVEAcare Neuromodulation System Safety [Time frame: 30 days]
Secondary outcome measures (8)
- Seizure Frequency [Time frame: 3 months]
- Seizure Severity [Time frame: 3 months]
- Change in Quality of Life [Time frame: 3 months]
- Participant View of Overall Status [Time frame: 6 months]
- Clinician View of Overall Status [Time frame: 6 months]
- Depression [Time frame: 6 months]
- Anti-seizure Medication Use [Time frame: 6 months]
- IPG Replacement Assessment [Time frame: At implant]
Eligibility criteria
Inclusion criteria
- 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.
- Anti-seizure medications must be at a steady state for a minimum of 30 days and remain stable through the 6-month post-activation study visit. Rescue medications may still be used as necessary
Exclusion criteria
- 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).
- Known vagal neuropathy, or other reasons that the left vagus nerve is not appropriate for implant.
- Vocal cord paralysis.
- Prior therapeutic brain surgery for epilepsy within 6 months prior to the baseline visit.
- Currently implanted with an Implantable Cardiac Defibrillator (ICD), pacemaker, Deep Brain Stimulator (DBS), Responsive Neurostimulator (RNS), Spinal Cord Stimulator (SCS), Peripheral Nerve Stimulator (PNS), Sacral Nerve Stimulator (SNS), carotid baroreceptor stimulator, cochlear implant, or currently using external stimulation devices such as a Transcutaneous Electrical Nerve Stimulator (TENS). Note: Participants who currently have a commercially available VNS system for drug-resistant epilepsy and are eligible for a generator replacement (due to nearing end of life) can receive the iVEAcare Implantable Pulse Generator (IPG) alone if their existing lead has been confirmed to be functioning properly preoperatively and intraoperatively.
- Pregnant or planning to be pregnant in the next 12 months. .
- Any active malignant disease (not including skin cancer).
- Any active infection in the vicinity of the implant site or any systemic infection.
- Poorly controlled diabetes (Type I or Type II) determined by HbA1c >8% (or > 64 mmol/mol
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 3 centers
- The Mater — South Brisbane
- St. Vincent's Hospital — Fitzroy
- The Alfred Hospital — Melbourne
Identifiers
NCT: NCT07640191 · CLN-000001