Sun Yat-Sen Prospective Cohort Study of Central Nervous System Idiopathic Inflammatory Demyelinating Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Long-term neurological function
研究概览
简要总结
The goal of this observational study is to learn about pathogenesis and clinical prognosis of CNS IIDD in the Chinese population and to provide evidence-based clues for clinical treatment decisions.
The main questions it aims to answer are:
Question 1: Clarify the clinical characteristics and prognostic factors of various diseases (MS, NMOSD, MOGAD, etc.) within IIDD in the Chinese population.
Question 2: Analyze the relationship between biomarkers and the occurrence, progression, and prognosis of CNS IIDD cases in our hospital.
Participants will
- Receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus, without additional special interventions.
- Receive clinical evaluation, follow-up, and management from dedicated neuroimmunology specialists.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years with central nervous system idiopathic inflammatory demyelinating diseases (CNS IIDD);
- •The clinical syndrome of the attack meets one of the following: MS, NMOSD, MOGAD, ADEM, clinically isolated syndrome, demyelinating encephalopathy, demyelinating myelitis, or brainstem encephalitis (see below A-E);
- •Agree to participate in this study and sign the informed consent form.
排除标准
- •History of tumors or diagnosis of central nervous system tumors;
- •Infectious lesions of the central nervous system;
- •Hereditary, metabolic, toxic, vascular, or traumatic demyelinating diseases of the brain/spinal cord;
- •Non-compliance with treatment and follow-up.
结局指标
主要结局
Long-term neurological function
时间窗: Through study completion, an average of 5 years
Assessed using the Expanded Disability Status Scale (EDSS)，EDSS score ranges from 0 to 10, with 0 indicating a normal healthy state, 10 indicating death, and higher scores reflecting more severe disability.
Relapse
时间窗: Through study completion, an average of 5 years
Must meet the following criteria：① Appearance of new symptoms or worsening of existing symptoms;② Symptoms attributed to CNS IIDD;③ Duration ≥24 hours;④ Increase in clinical scores (e.g., EDSS);⑤ Imaging or electrophysiological tests clearly showing new responsible lesions.
次要结局
- Long-term neurological function(Baseline, six months, one year, two years, and average three years)
- Sub-scores of the Expanded Disability Status Scale (EDSS)(Baseline, six months, one year, two years, and average three years)
- Optical coherence tomography (OCT) of the eyes: retinal nerve fiber layer thickness, macular thickness(Baseline, six months, one year, two years, and average three years)
- Changes in pathogenic antibody titers(Baseline, six months, one year, two years, and average three years)
- P100 amplitude of visual evoked potentials(Baseline, six months, one year, two years, and average three years)
- P100 latency of visual evoked potentials(Baseline, six months, one year, two years, and average three years)
- Latency of somatosensory evoked potentials;(Baseline, six months, one year, two years, and average three years)
- Changes in humoral immune markers(Baseline, six months, one year, two years, and average three years)
- Latency of brainstem auditory evoked potentials;(Baseline, six months, one year, two years, and average three years)
- Amplitude of somatosensory evoked potentials;(Baseline, six months, one year, two years, and average three years)
- Amplitude of brainstem auditory evoked potentials;(Baseline, six months, one year, two years, and average three years)