NCT07640191Recruiting
Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Jun 2026
- Start date
- 29 Jul 2026
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- iVEAcare
- Diseases
- Epilepsy
- NCT number
- NCT07640191
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 29 Jul 2026 to the primary completion date, 31 Jul 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Lab values
- Poorly controlled diabetes (Type I or Type II) determined by HbA1c \>8% (or \> 64 mmol/mol
Other
- Vocal cord paralysis.
- Pregnant or planning to be pregnant in the next 12 months. .
Who the study is looking for
- 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
Age in the registry: 4 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| St. Vincent's Hospital Coordinator of this site? Confirm its status | Fitzroy | Australia | Recruiting |
| Austin Hospital Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| Royal Brisbane & Women s Hospital Coordinator of this site? Confirm its status | Herston | Australia | Recruiting |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Melbourne Health Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| The Mater Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.