Drug Resistant, Drug-resistant Focal Epilepsy, Epilepsies, Focal, Epilepsy, Focal Epilepsy
Conditions
Brief summary
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.
Interventions
PROCEDURELaser technology for intracerebral thermocoagulation
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.
Sponsors
Medtronic
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of post-surgical complication of grade greater or equal to 2 according to Mathon and al classification | Day 30 post-operative | To assess the safety and feasibility of laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seizure freedom evaluated with ILAE (International League Against Epilepsy) classification | Post surgery : Month 1, Month 3, Month 6, Month 12 | Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications. |
| Number of seizure per patient | Post surgery : Month 1, Month 3, Month 6, Month 12 | Evaluate the frequency of seizure |
| Number of patient with at least one seizure with complex partial seizure | Post surgery : Month 1, Month 3, Month 6, Month 12 | Evaluate the intensity of seizure after treatment. |
| Number of patient at least one modification of anti-epileptic treatment | Post surgery : Month 1, Month 3, Month 6, Month 12 | Evaluation of clinical efficacy of treatment |
| Mean change of quantification of the number of interictal peaks over 30 minutes evaluated at surface EEG compared to the pre surgery surface EEG | Post surgery : Month 3, Month 6, Month 12 | Electrophysiological epileptic efficacy |
| Seizure freedom evaluated with Engel classification | Post surgery : Month 1, Month 3, Month 6, Month 12 | Evaluate the clinical epileptic efficacy of treatment based by the ILAE and Engel classifications. |
| Mean change in Quality of Life in Epilepsy (QOLIE-31) scores | Post surgery : Month 6, Month 12 | Evaluate the effect on quality of life by comparing the preoperative assessment with the postoperative assessments. |
| Incidence of adverse events | Day of surgery, Day 2, Day 7, Day 30 post-operative | Evaluate the clinical tolerance of the procedure. |
| Mean consumption of anti-epileptic drugs and epilepsy-related care | Post surgery : Month 12 | To assess the medico-economic impact of the treatment |
| Mean of major and minor axis measurements evaluated by measuring post-treatment morphological MRI images corresponding to induced necrosis in T1 gadolinium SPGR MRI | Month 1, Month 3, Month 12 | Evaluate the radiological epileptic efficacy of treatment |
| Mean change neuropsychological scores | Post surgery : Month 12 | 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 |
Countries
France
Contacts
Primary ContactBertrand Mathon, MD
Outcome results
None listed