COLETTE : Study of the Pathophysiology of Status Epilepticus and Dysimmune Encephalitis and Identification of Valuable Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Identification of (i) antibodies in the plasma and in the cerebrospinal fluid of patients with dysimmune encephalitis and (ii) biomarkers for neuronal death in the plasma and in the cerebrospinal fluid of patients with status epilepticus
研究概览
简要总结
COLETTE is an interventional study for which blood, cerebrospinal fluid and post-mortem tissues are collected in patients with status epilepticus or epilepsy associated to dysimmune encephalitis as well as in control patients, to better understand the pathophysiology of these severe epileptic disorders.
详细描述
Epilepsy is one of the most common neurological condition which concerns around 50 million people worldwide. Epilepsy is characterized by a lasting predisposition to generate seizures. Epilepsy can present as heterogenous set of clinical symptoms and is related to extremely varied etiologies. Some epilepsies are triggered by antineuronal autoantibodies and/or complicated by a status epilepticus. These conditions may induce brain atrophy, and severe neurological sequels.
The severity of these epilepsies requires significant efforts to (i) identify new therapeutic strategies able to control the evolution of dysimmune encephalitis and refractory status epilepticus, (ii) to identify their etiologies and (iii) to propose neuroprotective strategies.
Therefore, the investigators will organize a collection of biological samples (blood, cerebrospinal fluid, post-mortem brain tissues) and paraclinical data (electroencephalogram, evoked potential, CT, MRI) in patients with severe epilepsies, whether or not associated with autoantibodies, and/or evolving into status epilepticus.
This study should bring new insights allowing to better understand mechanisms that trigger the emergence of an epileptic brain (epileptogenesis) through :
(i) the identification and characterization of new pathophysiological pathways involving autoimmunity directed against the cerebral cortex and associated with severe epilepsy (ii) the identification and characterization of pathophysiological pathways participating in the excitotoxicity observed in status epilepticus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 2 years or above, with status epilepticus.
- •Affiliation to a French social security system excluding "Aide Médicale" Etat (AME).
- •Patients or relatives have been informed and given free informed and written consent to participate
- •Patients under legal protection (guardianship, curatorship) or not
- •Patients aged 2 years or above, with clinical signs of epilepsy associated to dysimmune encephalitis.
- •Affiliation to a French social security system excluding "Aide Médicale" Etat (AME).
- •Patients or relatives have been informed and given free informed and written consent to participate
- •Patients under legal protection (guardianship, curatorship) or not
- •Patients aged 18 years or above, without status epilepticus and/or dysimmune encephalitis.
- •Affiliation to a French social security system excluding "Aide Médicale" Etat (AME).
- •Patients or relatives have been informed and given free informed and written consent to participate
- •Patients under legal protection (guardianship, curatorship) or not
排除标准
- •Women with known or clinically detected pregnancy.
- •Patient deprived of liberty
- •Patients with known neurodegenerative disease.
- •Women with known or clinically detected pregnancy.
- •Patient deprived of liberty
- •Patients have been already treated by corticoids or IgIV.
- •Women with known or clinically detected pregnancy.
- •Patient deprived of liberty.
- •Patients with status epilepticus.
- •Patients with known neurodegenerative disease, brain tumor, severe head trauma, meningitis, subarachnoid hemorrhages, stroke.
研究组 & 干预措施
Group 1 : Status epilepticus
干预措施: Blood sampling, cerebrospinal fluid, stool sampling post-mortem cerebral tissues (NA for the Group 3) (Other)
Group 2 : Dysimmune encephalitis
干预措施: Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3) (Other)
Group 3 : Control patients
干预措施: Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3) (Other)
结局指标
主要结局
Identification of (i) antibodies in the plasma and in the cerebrospinal fluid of patients with dysimmune encephalitis and (ii) biomarkers for neuronal death in the plasma and in the cerebrospinal fluid of patients with status epilepticus
时间窗: 9 months and 24 months
Looking for antibodies with cell-based binding assay or monospecific recombinant assay. Identification of biomarkers for neuronal death with electrochemiluminometric sandwich immunoassays (Kryptor and ModularE170, Roche Diagnostic)
次要结局
- Identification of new dysimmune abnormalities(9 months and 24 months)
- Identification of specific EEG patterns associated to dysimmune encephalitis and/or status epilepticus(9 months and 24 months)
- Identification of new genetic pathways associated to dysimmune encephalitis and status(9 months and 24 months)
- Identification of new metabolic pathway that may participate in the excitotoxicity observed in status epilepticus or dysimmune encephalitis(9 months and 24 months)