Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epil… (NCT07640191) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy
30 participantsStarted 2026-06
Plain-language summary
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.
Who can participate
Age range
4 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key 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
Key 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), ca…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.