Testing an implanted nerve stimulator for epilepsy that medicines do not control
Tests the iVEAcare implanted stimulator in people with drug-resistant epilepsy.
Plain-language title generated from the registry record
Registry title: Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy
Key facts
- Where
- Clayton, Fitzroy, Heidelberg, Herston, Melbourne, Parkville, and South Brisbane, AustraliaSee the 7 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 4 and 75 years old?
Source: NCT07640191, who can take part
Where in Australia
- Monash HealthClayton, AustraliaTaking people
- St. Vincent's HospitalFitzroy, AustraliaTaking people
- Austin HospitalHeidelberg, AustraliaTaking people
- Royal Brisbane & Women s HospitalHerston, AustraliaTaking people
- The Alfred HospitalMelbourne, AustraliaTaking people
- Melbourne HealthParkville, AustraliaTaking people
- The MaterSouth Brisbane, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- iVEAcare
- Trial code
- NCT07640191
- Record updated
- 22 September 2026
- Original description
The purpose of this study is to assess the safety and performance of the iVEAcare Neuromodulation System for the treatment of drug-resistant epilepsy.Read full original descriptionShow less
Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy
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.
Inclusion: 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: Unsuitable for iVEAcare Neuromodulation System implant surgery; Previous left vagotomy (left vagus nerve cut to treat another disorder); Known vagal neuropathy, or other reasons that the left vagus nerve is not appropriate for implant; 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; Deteriorating neurologic or other deteriorating medical conditions; A condition currently requiring diathermy treatment anywhere in their body (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy); 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; Vocal cord paralysis; Pregnant or planning to be pregnant in the next 12 months. .