Interest Balance Auto-immune Population in Patients With Focal Epilepsy of Unknown Cause, Not Structural, Not Genetics, Newly Diagnosed
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- anti-neuronal antibodies
研究概览
简要总结
The knowledge of encephalitis associated with antibodies targeting intracellular antigens, and neuronal surface antibody syndromes has expanded considerably in recent times.
The primary purpose of the investigators protocole is to determine the incidence of anti-neuronal antibodies (blood and CSF) in a population of patients suffering from focal epilepsy of unknown cause to guide the management of these patients.
The investigators hypothesis is that dysimmune encephalitis is more common than is suggested by the current literature, and that sometimes forms of encephalitis dysimmune "at minimum" can be observed only in the form of focal epilepsy without further manifestation associated.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18-65 years
- •Presenting focal epilepsy on the following arguments
- •Crisis with clinical symptoms indicating focal seizure
- •& / Or crisis or critical focal inter-recorded on EEG interpreted by a neurologist with expertise in the field of epilepsy.
- •Having not yet received a CSF analysis
- •From unknown cause:
- •No evidence of injury (excluding temporal or hyperintensity of hippocampal sclerosis) on brain MRI with focus on regions of interest cuts.
- •No discharge or generalized photosensitivity recorded over an extended interpreted by a neurologist with expertise in the field of epilepsy video-EEG.
- •No argument for metabolic or neurodegenerative genetic epilepsy.
- •Normal neurological examination.
- •Epilepsy that started within a period of two years preceding the study entry (including vegetative symptoms of temporal focal seizures).
- •Without treatment or as benzodiazepines or taking anti-epileptic first-line monotherapy (excluding benzodiazepines).
- •Informed consent signed
- •affiliated with a social security scheme
排除标准
- •structural abnormality found in brain MRI (except temporal hyperintensity and / or sclerosis of the hippocampus).
- •Background Neurological: hyperthermic seizures in childhood, neonatal distress, history of seizures related to a circumstance, inflammation or infection of the CNS.
- •Taking toxic: chronic alcoholism, narcotic consumption
- •The case for a genetic / metabolic neurodeg ear /: generalized EEG / photosensitivity / family history of epilepsy / autism / disorder syndrome psychomotor development / dysmorphic syndrome / extrapyramidal syndrome associated discharge
- •History of thyroiditis or m. system (LEAD, SGS, PR, Sarcoidosis)
- •Immunosuppression innate or acquired
- •IC lumbar puncture or have already received a lumbar puncture before inclusion in the protocol.
- •Person under supervision or guardianship.
结局指标
主要结局
anti-neuronal antibodies
时间窗: 2 years
Incidence of seropositive patients for anti-neuronal antibodies in a cohort of patients with focal epilepsy of unknown cause.
次要结局
- statistically significant differences between people with and without-neuronal antibodies differences(2 years)