Relapse and Functional Outcomes in Anti-LGI1 Encephalitis: A Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Relapse
研究概览
简要总结
This study focuses on a rare brain disease called anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis. In this condition, the body's immune system mistakenly attacks a protein in the brain, which can cause problems with memory, thinking, behavior, and seizures. While most patients get better with initial treatments, some continue to have long-term symptoms or experience a return of the disease (called a "relapse") months or years later. The goal of this study is to understand how often these relapses and long-term problems happen and to identify which patients are most at risk.
The investigators will look back at the medical records of patients diagnosed with anti-LGI1 encephalitis at five major hospitals in Eastern China. The information about their symptoms, the treatments they received and how they recovered over time are obtained. Then, the investigators will analyze this information to find out what factors are linked to having a relapse or a poor long-term recovery.
By understanding the risks for relapse and poor outcomes, doctors can better identify which patients need closer monitoring and more long-term treatment strategies. The results of this study will help create better guidelines for managing patients with this disease after their initial recovery, aiming to improve their quality of life in the long run.
详细描述
- Study Background:
Anti-LGI1 encephalitis is an autoimmune disorder where the body produces antibodies that attack the brain, leading to symptoms like memory loss, psychiatric issues, and seizures. Initial treatments with immunotherapy (like steroids) are effective for most patients. However, a significant number of patients are left with lasting neurological problems, and some experience a return of the disease (relapse) after a period of improvement. The rates of relapse and poor long-term outcomes reported in previous studies vary widely, and it is not clear which patients are most vulnerable. Furthermore, the best strategy for long-term treatment after the initial phase to prevent relapses is not well-established. 2. Study Objectives
This study aims to:
- Describe how often patients with anti-LGI1 encephalitis experience a relapse of the disease.
- Assess their long-term functional recovery.
- Identify patient characteristics, symptoms, or treatment factors that may increase the risk of relapse or poor recovery.
- Data Collection
Data was gathered from electronic medical records and, when necessary, follow-up phone interviews. The information collected includes:
- Patient Demographics: Age, sex.
- Initial Illness: Symptoms at diagnosis, severity of the disease.
- Test Results: Findings from brain scans (MRI), brain wave tests (EEG), antibody levels and other relevant information.
- Treatments: Primarily types and durations of immunotherapy received (e.g., steroids, intravenous immunoglobulin, and maintenance immunosuppressants).
- Outcome Definitions
- Relapse: The return of new or worsening symptoms after the patient had been stable or improving for at least 3 months.
- Functional Outcome: The patient was largely independent in their daily activities at the last follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Characteristic presentations of anti-LGI1 encephalitis;
- •LGI1-immunoglobulin G (IgG) positivity in serum and/or cerebrospinal fluid (CSF) by fixed cell-based assay (Euroimmun, Lübeck, Germany)
- •follow-up ≥ 18 months after initial immunotherapies
- •exclusion of alternative diagnoses
排除标准
- •presence of coexisting neural autoantibodies
- •history of central nervous system (CNS) infections, severe neurological or primary psychiatric disorders
- •no prior use or lack of first-line immunotherapy
- •insufficient follow-up data
结局指标
主要结局
Relapse
时间窗: Through study completion, with the last follow-up date in January 2026
the presence of new or worsening clinical features after at least 3 months of stability or improvement
次要结局
- Functional outcomes(Through study completion, with the last follow-up date in January 2026)
研究者
Shen Chun-Hong
Associate Senior Doctor
Second Affiliated Hospital, School of Medicine, Zhejiang University