Sun Yat-Sen Cohort of CNS Idiopathic Inflammatory Demyelinating Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, MS, Neuromyelitis Optica Spectrum Disorders, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Acute Disseminated Encephalomyelitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sun Yat-Sen Prospective Cohort Study of Central Nervous System Idiopathic Inflammatory Demyelinating Diseases
Overview
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 [Time frame: Through study completion, an average of 5 years]
- Long-term neurological function [Time frame: Through study completion, an average of 5 years]
Secondary outcome measures (11)
- Long-term neurological function [Time frame: Baseline, six months, one year, two years, and average three years]
- Sub-scores of the Expanded Disability Status Scale (EDSS) [Time frame: 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 [Time frame: Baseline, six months, one year, two years, and average three years]
- Changes in humoral immune markers [Time frame: Baseline, six months, one year, two years, and average three years]
- Changes in pathogenic antibody titers [Time frame: Baseline, six months, one year, two years, and average three years]
- P100 amplitude of visual evoked potentials [Time frame: Baseline, six months, one year, two years, and average three years]
- P100 latency of visual evoked potentials [Time frame: Baseline, six months, one year, two years, and average three years]
- Latency of somatosensory evoked potentials; [Time frame: Baseline, six months, one year, two years, and average three years]
- Latency of brainstem auditory evoked potentials; [Time frame: Baseline, six months, one year, two years, and average three years]
- Amplitude of somatosensory evoked potentials; [Time frame: Baseline, six months, one year, two years, and average three years]
- Amplitude of brainstem auditory evoked potentials; [Time frame: Baseline, six months, one year, two years, and average three years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Sun Yat-sen Memorial Hospital — Guangzhou
Identifiers
NCT: NCT06541626 · SYSKY-2024-109-01