The Diagnostic Value of Autoimmune Antibody Detection in Newly Onset and Chronic Epilepsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 主要终点
- change of the autoimmune antigen
研究概览
简要总结
multi-central and prospectively study the diagnostic value of autoimmune antibody detection in new and chronic epilepsy, and provide reference for clinical practice
详细描述
multi-centrally recruit patients with newly onset or chronic epilepsy and hoping to find whether there exist an autoimmune cause. whether the patients receive immune therapy or not will depend on the type and titter of the autoimmune antibody as well as the severity of the symptom. At 3 and 6 months later, all patients will be followed-up, and the positive autoimmune antibody will be redetected. the clinical manifest, clinical data, medication and treatment outcome will be recorded and analyzed, to study the diagnostic value of autoimmune antibody detection in new and chronic epilepsy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with epilepsy according to the diagnostic criteria of International League Against Epilepsy (ILAE) 2017
- •Age from 16 to 70 years old
- •The etiology of patients with epilepsy is unknown
- •The patient or guardian signs an informed consent and can cooperate with the inspection and follow-up for six months
排除标准
- •Patients with hereditary, infectious, and metabolic epilepsy
- •The investigation and follow-up cannot be completed due to vision, hearing, language expression, disturbance of consciousness, and impaired understanding, and the guardian cannot replace the completed
- •Patients with other progressive or systemic diseases
结局指标
主要结局
change of the autoimmune antigen
时间窗: at six months after the patients being enrolled
autoimmune antigen in the serum of patients was described as positive and negative. the change of the autoimmune antigen include 'turn negative' and 'still positive' compared to the first detection.
change of the seizure frequency
时间窗: at six months after the patients being enrolled
Seizure frequency are described as no seizures, less than one per month, monthly, weekly, and daily. the change of seizure frequency include 'increased', 'decreased', and 'no change' compared to the frequency before they were enrolled
次要结局
未报告次要终点