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

NCT07591350 | Not Yet Recruiting DMC

• 1 other identifier: APHP240803
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Epilepsy

Keywords

Epilepsy; HIFU; drug-resistant epilepsy; thermoablation; Epilepsy surgery

Outcome Measures

Primary Outcomes (1)

• Target ablative temperature

  Achievement of the target ablative temperature (at least one timepoint at 52 °C (15 °C above body temperature)) on calorimetric MRI sequences performed in real time during HIFU treatment (real-time quantitative measurements + CSV data extracted at the end of the procedure).

  During the procedure between 60 and 75 days after inclusion

Secondary Outcomes (13)

• Post-intervention complications of grade≥2

  From day 0 to day 30 after the procedure.

• Morphological MRI

  From the day of the procedure up to 12 months after the procedure.

• Thermometric MRI monitoring during HIFU thermoablation

  At D0 during the procedure

• Cumulative thermal dose during HIFU thermoablation

  At D0 during the procedure

• ILAE classification

  At 12 months after the procedure

Study Arms (1)

Assigned Interventions

EXPERIMENTAL

Procedure: MR-guided HIFU thermoablation; Diagnostic Test: EEG; Diagnostic Test: MRI

Interventions

MR-guided HIFU thermoablation PROCEDURE

\- 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.

Assigned Interventions

EEG DIAGNOSTIC_TEST

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

Assigned Interventions

MRI DIAGNOSTIC_TEST

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.

Assigned Interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Drug-sensitive epilepsy
• Patients exhibiting suboptimal adherence to medication
• Individuals under legal protective measures
• Patients presenting contraindications to Magnetic Resonance Imaging (MRI), such as the presence of metal fragments, allergy to gadolinium, etc.
• Patients with serious and uncontrolled psychiatric disorders
• Pregnant women. Women of reproductive capacity were mandated to use oral contraceptives throughout the study duration.
• Contraindications related to ExAblate treatment:
• patients with implants in the brain or skull.
• patients where it is not possible to avoid energy-absorbing structures or sensitive tissues (e.g., skull density ratio \<0.35, areas of anterior brain shunts, surgical clamps, or other hard implants) on the path of the ultrasound beam.
• patients diagnosed with another brain disease (e.g., malignant brain tumors or intracranial aneurysms).
• patients with a history of cerebral hemorrhage, and stroke within the last year.
• patients taking medications that are predisposed to bleeding and have not stopped for two weeks before the procedure.
• patients with severe hypertension that cannot be controlled with medication (diastolic blood pressure \>100 mmHg).
• patients who could not communicate with the physician during the treatment.
• patients with unstable cardiac conditions.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Epilepsy; Drug Resistant Epilepsy

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Bertrand Mathon, MD PhD

CONTACT

+ 33 1 42 16 34 08; bertrand.mathon@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot, single-center study is single arm, prospective, non-comparative and uncontrolled.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 15, 2026

Record last verified: 2026-05