Clinical Evaluation of Interstitial Laser Thermal Therapy Under Continuous MRI Monitoring as a Minimally Invasive Treatment of Patients With Medically Unbalanced Partial Epilepsy
试验速览
- 阶段
- 1 期
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Frequency of post-surgical complication of grade greater or equal to 2 according to Mathon and al classification
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Frequency of post-surgical complication of grade greater or equal to 2 according to Mathon and al classification
时间窗: Day 30 post-operative
To assess the safety and feasibility of laser-induced thermocoagulation of intracerebral lesions responsible for drug-resistant epilepsy.
次要结局
- Seizure freedom evaluated with ILAE (International League Against Epilepsy) classification(Post surgery : Month 1, Month 3, Month 6, Month 12)
- Number of seizure per patient(Post surgery : Month 1, Month 3, Month 6, Month 12)
- Number of patient at least one modification of anti-epileptic 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(Post surgery : Month 3, Month 6, Month 12)
- Mean change neuropsychological scores(Post surgery : Month 12)
- Incidence of adverse events(Day of surgery, Day 2, Day 7, Day 30 post-operative)
- Seizure freedom evaluated with Engel classification(Post surgery : Month 1, Month 3, Month 6, Month 12)
- Number of patient with at least one seizure with complex partial seizure(Post surgery : Month 1, Month 3, Month 6, Month 12)
- Mean change in Quality of Life in Epilepsy (QOLIE-31) scores(Post surgery : Month 6, Month 12)
- Mean consumption of anti-epileptic drugs and epilepsy-related care(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(Month 1, Month 3, Month 12)