RecruitingNot ApplicableNCT07640191

Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy


Sponsor

iVEAcare

Enrollment

30 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 4 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called iVEAcare Neuromodulation System for people with drug resistant epilepsy. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEiVEAcare Neuromodulation System

iVEAcare Neuromodulation System implant


Locations(2)

The Mater

South Brisbane, Queensland, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT07640191


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