MedTrace Logo

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

NCT07640191 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-06

No results posted yet for this study

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.

Conditions

  • Drug Resistant Epilepsy

Interventions

DEVICE

iVEAcare Neuromodulation System

iVEAcare Neuromodulation System implant

Sponsors & Collaborators

  • iVEAcare

    lead INDUSTRY

Principal Investigators

  • Terence O'Brien, MD · The Alfred Hospital and Monash University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-29
Primary Completion
2027-07-31
Completion
2032-07-31

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07640191 on ClinicalTrials.gov