NCT07591350Toborzás még nem indult
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 15.
Rövid összefoglaló (regiszter, angolul)
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).
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 13 (tervezett)
- Első benyújtás
- 2026. ápr. 16.
- Kezdés
- 2026. szept.
- Elsődleges befejezés
- 2028. nov.
- Fő szponzor
- Assistance Publique - Hôpitaux de Paris
- Betegségek
- Epilepszia
- NCT-szám
- NCT07591350
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 13
- 2026. szept. és az elsődleges befejezés (2028. nov.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- 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.
Más betegség
- 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
Egyéb
- Individuals under legal protective measures
- Pregnant women. Women of reproductive capacity were mandated to use oral contraceptives throughout the study duration.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.