Assessment of MRI-guided HIFU for Patients With Drug-resistant Focal Epilepsy (NCT07591350) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Assessment of MRI-guided HIFU for Patients With Drug-resistant Focal Epilepsy
13 participantsStarted 2026-09
Plain-language summary
The goal of this clinical trial is to assess the feasibility, safety, and tolerance of MRI-guided High-Intensity Focused Ultrasound (HIFU) for the treatment of drug-resistant focal epilepsy in adult patients with MRI-visible brain lesions.
The main question it aims to answer is whether HIFU can safely and effectively achieve the target ablative temperature (≥52 °C) within epileptogenic lesions, thereby enabling successful thermal ablation of the epileptogenic focus.
This pilot, single-center study is single arm, prospective, non-comparative and uncontrolled. This will take place over a period of 24 months. After information (V1), inclusion (V2) and presurgical (V3) visits, a surgical visit will be performed during hospitalization in the neurosurgery department (V4) for HIFU therapy and 5 follow-up consultation visits (V5, V6, V7, V8, and V9 to J7, M1, M3, M6, and M12).
Who can participate
Age range
18 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.
Inclusion criteria
. Age ≥18 years old
. Patient with drug-resistant epilepsy according to ILAE definition
. Patient presenting lesional image(s) on morphological MRI responsible for epilepsy according to clinical and electrophysiological evaluation, +/-PET+/- SPECT+/-sEEG
. Patients for whom neurosurgical treatment by craniotomy is not possible: deep-seated lesions, lesions in the eloquent area, patient reluctance to have a surgical procedure with craniotomy, contraindication to general anesthesia
. Patient affiliated to a social security scheme
. The patients signed an informed consent form.
Exclusion criteria
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.
What they're measuring
1
Target ablative temperature
Timeframe: During the procedure between 60 and 75 days after inclusion