NCT07591350Not yet recruiting
Assessment of MRI-guided HIFU for Patients With Drug-resistant Focal Epilepsy
Clinical and Radiological Assessment of MRI-guided High-intensity Focused Ultrasound for Patients With Drug-resistant Focal Epilepsy
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- First submitted
- 16 Apr 2026
- Start date
- Sept 2026
- Primary completion date
- Nov 2028
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Epilepsy
- NCT number
- NCT07591350
What you commit to
- Study type: Interventional
- Planned participants: 13
- From Sept 2026 to the primary completion date, Nov 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients exhibiting suboptimal adherence to medication
- 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.
- patients with history of abnormal bleeding, intracranial hemorrhage, coagulopathy, or documented risk factors for intraoperative or postoperative bleeding or coagulopathy.
- patients with cerebrovascular disease (multiple strokes or strokes within six months).
- patients with risk factors for intraoperative or postoperative bleeding.
- patients with significant healing in an area located on the path of the intended passage of energy to the treatment area.
Other illness
- Drug-sensitive epilepsy
- 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
Other
- Individuals under legal protective measures
- Pregnant women. Women of reproductive capacity were mandated to use oral contraceptives throughout the study duration.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.