A Prospective Study to Evaluate Clinical Outcomes in Patients With Anti-leucine-rich Glioma-inactivated 1 Encephalitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- seizure outcomes
研究概览
简要总结
Anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis has been increasingly identified as the second most common type of autoimmune encephalitis after anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis. It presents with acute or subacute onset of epileptic seizures, anterograde amnesia, behavior disturbances, sleep disorders and hyponatremia. In most patients with anti-LGI1 encephalitis, immunotherapy is successful in treating the encephalitis. However, relapses, chronic epilepsy, cognitive declines and psychiatric problems have been reported in some cases.
So far, prospective studies to evaluate its clinical outcomes still remain limited. In this project, the investigators will use clinical features and advanced paraclinical examinations to prospectively investigate the clinical outcomes and the associated factors in patients with anti-LGI1 encephalitis.
详细描述
In this prospective study, the investigators are aiming to recruit newly diagnosed patients with anti-LGI1 encephalitis. At the acute stage and during the follow-up, some routine and advanced paraclinical examinations will be conducted, including dynamic blood and/or cerebrospinal fluid (CSF) test, multimodal brain magnetic resonance imaging (MRI) including functional MRI, diffusion tensor imaging, arterial spin labeling, et al), Electroencephalography (EEG) or continuous video-EEG (VEEG), positron emission tomography (PET), neuropsychological tests and some other paraclinical examinations. Through the comprehensive analysis, the clinical outcomes and associated factors are further explored in anti-LGI1 encephalitis.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the 2016 consensus diagnostic criteria for anti-LGI1 encephalitis.
- •Newly diagnosed, and during the acute stage before study enrollment.
- •Sign the informed consent form.
排除标准
- •with the diagnosis of epilepsy, stroke, cerebral trauma, and/or other nervous system disease prior to the onset of encephalitis.
- •with coexisting antibodies, such as anti-contactin-associated protein 2 (CASPR2) antibody.
- •Lost to follow-up.
结局指标
主要结局
seizure outcomes
时间窗: 1 year, 2 year
The incidence of different seizure outcomes and associated factors will be analyzed.
Clinical severity and recovery 1
时间窗: 1 year, 2 year
modified Rankin scale, ranging from 0-6, higher scores mean a worse outcome
Clinical severity and recovery 2
时间窗: 1 year, 2 year
clinical assessment scale for autoimmune encephalitis, ranging from 0-27, higher scores mean a worse outcome
Incidence of recurrence
时间窗: 1 year, 2 year
a relapse of encephalitis
次要结局
- Memory assessment 2(1 year, 2 year)
- Memory assessment 1(1 year, 2 year)
- Brain volume(1 year, 2 year)
研究者
Shen Chun-Hong
Associate Senior Doctor
Second Affiliated Hospital, School of Medicine, Zhejiang University