About this trial
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
1. Receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus, without additional special interventions. 2. Receive clinical evaluation, follow-up, and management from dedicated neuroimmunology specialists.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients are aged between 18 and 65 years and diagnosed with central nervous system idiopathic inflammatory demyelinating diseases
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
6
Trial groupsSee each trial group below.
Trial outcomes
Primary outcomes
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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.
Long-term neurological function
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.
Secondary outcomes
Long-term neurological function
Assessed using the Optic Spinal Impairment Scale (OSIS) and its sub-scores, OSIS score ranges from 0 to 25, and higher scores reflect more severe disability. OSIS sub-score ranges from 0 to 5-8, and higher scores reflect more severe in each component assessment.
Sub-scores of the Expanded Disability Status Scale (EDSS)
EDSS sub-score ranges from 0 to 5 or 6, with 0 indicating a normal healthy state, higher scores indicating worse neurological functions.
Optical coherence tomography (OCT) of the eyes: retinal nerve fiber layer thickness, macular thickness
The thickness is measured by machines by milimetres
Changes in humoral immune markers
The levels of neurofilament light chain (NfL), soluble GFAP, soluble TREM2, and other potential biomarkers are measured in g/ml.
Other outcomes
Recording of adverse reactions
Follow-up of common adverse reactions
Sponsors and contacts
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