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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: Laser technology for intracerebral thermocoagulation


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LITT technology<br>Laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy. | Procedure: Laser technology for intracerebral thermocoagulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 30 post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure freedom evaluated with Engel classification | Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications. | Post surgery : Month 1, Month 3, Month 6, Month 12 | 
| Seizure freedom evaluated with ILAE (International League Against Epilepsy) classification | Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications. | Post surgery : Month 1, Month 3, Month 6, Month 12 | 
| Number of seizure per patient | Evaluate the frequency of seizure | Post surgery : Month 1, Month 3, Month 6, Month 12 | 
| Number of patient with at least one seizure with complex partial seizure | Evaluate the intensity of seizure after treatment. | Post surgery : Month 1, Month 3, Month 6, Month 12 | 
| Number of patient at least one modification of anti-epileptic treatment | Evaluation of clinical efficacy of treatment | Post surgery : Month 1, Month 3, Month 6, Month 12 | 
| Mean change of quantification of the number of interictal peaks over 30 minutes evaluated at surface EEG compared to the pre surgery surface EEG | Electrophysiological epileptic efficacy | Post surgery : Month 3, Month 6, Month 12 | 
| Mean change neuropsychological scores | Evaluate the effect on cognition by a postoperative neuropsychological evaluation, compared with the pre-treatment neuropsychological evaluation.The neuro-psychological test will be selected according to the location of the lesion/focus | Post surgery : Month 12 | 
| Mean change in Quality of Life in Epilepsy (QOLIE-31) scores | Evaluate the effect on quality of life by comparing the preoperative assessment with the postoperative assessments. | Post surgery : Month 6, Month 12 | 
| Incidence of adverse events | Evaluate the clinical tolerance of the procedure. | Day of surgery, Day 2, Day 7, Day 30 post-operative | 
| Mean consumption of anti-epileptic drugs and epilepsy-related care | To assess the medico-economic impact of the treatment | Post surgery : Month 12 | 
| Mean of major and minor axis measurements evaluated by measuring post-treatment morphological MRI images corresponding to induced necrosis in T1 gadolinium SPGR MRI | Evaluate the radiological epileptic efficacy of treatment | Month 1, Month 3, Month 12 |