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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS | Diagnosis meets the 2017 McDonald diagnostic criteria, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus. | ||
| NMOSD | Diagnosis meets the 2015 IPND diagnostic panel standards, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus. | ||
| MOGAD | Diagnosis meets the 2023 international expert panel recommended standards, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus. | ||
| ADEM | Diagnosis meets the diagnostic criteria for ADEM | ||
| CIS | Diagnosis meets the 2017 McDonald diagnostic criteria, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus. | ||
| undefined CNS IIDD | First occurrence of CNS inflammatory demyelinating event, not yet diagnosable as MS, NMOSD, MOGAD, ADEM, or other definitive types of central nervous system demyelinating diseases, with symptoms and signs lasting more than 24 hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Relapse | Must meet the following criteria：①Appearance 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. | Through study completion, an average of 5 years |
| 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. | Through study completion, an average of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, six months, one year, two years, and average three years |
| Measure | Description | Time Frame |
|---|---|---|
| Recording of adverse reactions | Baseline, six months, one year, two years, and average three years | |
| Follow-up of common adverse reactions | Baseline, six months, one year, two years, and average three years |
Inclusion Criteria:
Exclusion Criteria:
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Patients are aged between 18 and 65 years and diagnosed with central nervous system idiopathic inflammatory demyelinating diseases
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongxuan Wang | Contact | 86+13824498978 | wanghx8@mail.sysu.edu.cn | |
| Wanru Chen | Contact | 86+13242800032 | chenwr23@mail2.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| 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. | 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 | The thickness is measured by machines by milimetres | Baseline, six months, one year, two years, and average three years |
| 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. | Baseline, six months, one year, two years, and average three years |
| Changes in pathogenic antibody titers | Titers of antibodies for MOG, AQP4, MBP, and AFO in iu/l | Baseline, six months, one year, two years, and average three years |
| P100 amplitude of visual evoked potentials | Amplitude in volts | Baseline, six months, one year, two years, and average three years |
| P100 latency of visual evoked potentials | Latency in seconds | Baseline, six months, one year, two years, and average three years |
| Latency of somatosensory evoked potentials; | Latency in seconds | Baseline, six months, one year, two years, and average three years |
| Latency of brainstem auditory evoked potentials; | Latency in seconds | Baseline, six months, one year, two years, and average three years |
| Amplitude of somatosensory evoked potentials; | Amplitude in volts | Baseline, six months, one year, two years, and average three years |
| Amplitude of brainstem auditory evoked potentials; | Amplitude in volts | Baseline, six months, one year, two years, and average three years |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009471 | Neuromyelitis Optica |
| D000098542 | Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease |
| D004673 | Encephalomyelitis, Acute Disseminated |
| D003711 | Demyelinating Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009188 | Myelitis, Transverse |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
| D056784 | Leukoencephalopathies |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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