Feasibility Study of the iVEAcare Neuromodulation System for the Treatment of Drug-Resistant Epilepsy
Recruiting now · Not applicable
Conditions studied: Drug Resistant Epilepsy
In brief
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.
Key facts
- Study ID
- NCT07640191
- Run by
- iVEAcare
- People needed
- 30
- Starts
- 2026-07-29
- Expected to finish
- 2032-07-01
- Last updated by the study team
- 2026-08-06
Who can join
Age: 4 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Mater — South Brisbane, Queensland, Australia (enrolling)
- St. Vincent's Hospital — Fitzroy, Victoria, Australia (enrolling)
- The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
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