Sun Yat-Sen Cohort of CNS Idiopathic Inflammatory Demyelinating Diseases
NCT Number: NCT06541626
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Multiple Sclerosis, MS|Neuromyelitis Optica Spectrum Disorders|Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease|Acute Disseminated Encephalomyelitis|Clinically Isolated Syndrome|Demyelinating Disorder
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-01-01
Completion Date: 2035-12-31
Locations: Sun Yat-sen Memorial Hospital, Guangzhou, Guangdong, 510120, China

Summary:
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.

Primary Outcome Measures: 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., 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
Secondary Outcome Measures: 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|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
Other Outcome Measures: 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