Sun Yat-Sen Cohort of CNS Idiopathic Inflammatory Demyelinating Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

450 Participants
are grouped into 6 trial groups

6

Trial groups

See each trial group below.

Group A: MS
Group B: NMOSD
Group C: MOGAD
Group D: ADEM
Group E: CIS
Group F: undefined CNS IIDD

Trial outcomes

Primary outcomes

1

Relapse

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.

Time frame
Through study completion, an average of 5 years
2

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.

Time frame
Through study completion, an average of 5 years

Secondary outcomes

1

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.

Time frame
Baseline, six months, one year, two years, and average three years
2

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.

Time frame
Baseline, six months, one year, two years, and average three years
3

Optical coherence tomography (OCT) of the eyes: retinal nerve fiber layer thickness, macular thickness

The thickness is measured by machines by milimetres

Time frame
Baseline, six months, one year, two years, and average three years
4

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.

Time frame
Baseline, six months, one year, two years, and average three years

Other outcomes

1

Recording of adverse reactions

Time frame
Baseline, six months, one year, two years, and average three years
2

Follow-up of common adverse reactions

Time frame
Baseline, six months, one year, two years, and average three years

Sponsors and contacts

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