Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy

Phase 1UnknownNCT05198882

Assistance Publique - Hôpitaux de Paris13 enrolled

Overview

Laser Induced Interstitial Thermal Therapy (LITT) is a "minimally invasive" procedure that uses the heat generated by a laser light (65°) to destroy brain lesions by coagulation leading to lesion necrosis under real-time MRI monitoring. The laser optical fiber is implanted into the lesion using stereotaxy. This technique, which can be performed under local anesthesia and on an outpatient basis, proved its efficacy and safety in the treatment of brain metastases for the first time in the world in 2006 (A. Carpentier et al, 2008, 2011). Since then, more than 5,000 patients have been treated in the USA, including for epileptogenic lesions (FDA device and CE cleared). Our goal is to evaluate LITT on lesions with drug-resistant epilepsy for which surgical resection is impossible. No therapeutic trial evaluating LITT in this indication has been performed to date. It is therefore necessary to study its feasibility and tolerance.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Drug-resistant Focal Epilepsy Epilepsy Epilepsies, Focal

Interventions

Laser technology for intracerebral thermocoagulationPROCEDURE

One intervention : LITT (Laser Interstitial Thermal Treatment), technology that uses laser energy to thermally destroy (photo-thermal treatment) a brain injury under continuous MRI control (Validated by FDA - CE marking). The operator console + surgical laser generator + software that manages the power delivered by the laser is connected to an MRI - Provided by MEDTRONIC - FDA approved and CE certified.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥18 years and \< 80 years 2. Patient with a medically unbalanced partial epilepsy 3. Patient with a lesional image(s) in morphological MRI responsible for epilepsy based on clinical and electrophysiological assessment, +/- PET +/- SPECT +/- MEG +/- sEEG 4. Patients for whom scheduled neurosurgical treatment with craniotomy appears difficult: Deep lesions, eloquent region lesions, patient reluctance to perform surgery. 5. Endorsement of the Multidisciplinary Meeting of Neuro-epileptology 6. Patient affiliated with a social security scheme 7. Patient who has signed prior, free and informed consent Exclusion Criteria: 1. Pharmacosensitive epilepsy 2. Patient with poor adherence to medication, or with psychological disorders 3. Patients under legal protection 4. Patient with a contraindication to MRI (metal shards, known allergy to gadolinium, etc.) 5. Anticoagulant and antiplatelet therapy underway, cannot be stopped. 6. Severe and unbalanced psychiatric disorders 7. Pregnant women. Women of childbearing age should use oral contraception throughout the study. 8. Allergy to local anaesthetics / general anaesthesia

Outcomes

Primary Outcomes

Frequency of post-surgical complication of grade greater or equal to 2 according to Mathon and al classification

To assess the safety and feasibility of laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.

Time frame: Day 30 post-operative