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

Assistance Publique - Hôpitaux de Paris

Status and phase: Enrolling; Phase 1

Conditions: Epilepsy; Epilepsies, Focal; Drug Resistant; Focal Epilepsy; Drug-resistant Focal Epilepsy

Treatments: Procedure: Laser technology for intracerebral thermocoagulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05198882

APHP200097

Details and patient eligibility

About

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.

Enrollment: 13 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

13 participants in 1 patient group

LITT technology

Experimental group

Description:

Laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.

Treatment:

Procedure: Laser technology for intracerebral thermocoagulation