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NOT YET RECRUITING
NCT07591350
NA

Assessment of MRI-guided HIFU for Patients With Drug-resistant Focal Epilepsy

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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).

Official title: Clinical and Radiological Assessment of MRI-guided High-intensity Focused Ultrasound for Patients With Drug-resistant Focal Epilepsy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2026-09

Completion Date

2029-12

Last Updated

2026-05-15

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

MR-guided HIFU thermoablation

\- HIFU-based thermoablation: non-invasive brain tissue ablation by a MRI-guided transcranial ultrasound (MRgFUS) system. • Installation of a stereotaxy frame: 4 cranial skin points under local anesthesia with Xylocaine, Perfalgan IV 2g in IVL, usual brushing protocol with iodized alcohol, and removal of stereotaxy frame • MRI with contrast agent administration acquisition and definition of the area to be treated and ultrasound parameters by neurosurgeons, neuroradiologists, and physicists. • Realization of thermoablation under real-time control using MRI and clinical control.

DIAGNOSTIC_TEST

EEG

Surface EEG: assessment of residual seizures and interictal epileptiform activity.

DIAGNOSTIC_TEST

MRI

Brain MRI in the Neuroradiology department to monitor lesion volume, possible reactive edema, and possible mass effect. The imaging protocol will include 3D T1, 3D T2, 3D FLAIR, SWI, Diffusion and 3D T1 after gadolinium injection sequences.