Acute Disseminated Encephalomyelitis, Clinically Isolated Syndrome, Demyelinating Disorder, Multiple Sclerosis, MS, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Neuromyelitis Optica Spectrum Disorders
Conditions
Keywords
CNS IIDD, follow-up
Brief 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.
Interventions
None listed
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
1. Patients aged 18-65 years with central nervous system idiopathic inflammatory demyelinating diseases (CNS IIDD); 2. 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); 3. Agree to participate in this study and sign the informed consent form.
Exclusion criteria
1. History of tumors or diagnosis of central nervous system tumors; 2. Infectious lesions of the central nervous system; 3. Hereditary, metabolic, toxic, vascular, or traumatic demyelinating diseases of the brain/spinal cord; 4. Non-compliance with treatment and follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse | Through study completion, an average of 5 years | 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 | Through study completion, an average of 5 years | 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
| Measure | Time frame | Description |
|---|---|---|
| Long-term neurological function | Baseline, six months, one year, two years, and average three years | 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) | Baseline, six months, one year, two years, and average three years | EDSS sub-score ranges from 0 to 5 or 6, with 0 indicating a normal healthy state, higher scores indicating worse neurological functions. |
| Changes in humoral immune markers | Baseline, six months, one year, two years, and average three years | The levels of neurofilament light chain (NfL), soluble GFAP, soluble TREM2, and other potential biomarkers are measured in g/ml. |
| Changes in pathogenic antibody titers | Baseline, six months, one year, two years, and average three years | Titers of antibodies for MOG, AQP4, MBP, and AFO in iu/l |
| P100 latency of visual evoked potentials | Baseline, six months, one year, two years, and average three years | Latency in seconds |
| Latency of somatosensory evoked potentials; | Baseline, six months, one year, two years, and average three years | Latency in seconds |
| Latency of brainstem auditory evoked potentials; | Baseline, six months, one year, two years, and average three years | Latency in seconds |
| Amplitude of somatosensory evoked potentials; | Baseline, six months, one year, two years, and average three years | Amplitude in volts |
| Amplitude of brainstem auditory evoked potentials; | Baseline, six months, one year, two years, and average three years | Amplitude in volts |
| P100 amplitude of visual evoked potentials | Baseline, six months, one year, two years, and average three years | Amplitude in volts |
| Optical coherence tomography (OCT) of the eyes: retinal nerve fiber layer thickness, macular thickness | Baseline, six months, one year, two years, and average three years | The thickness is measured by machines by milimetres |
Other
| Measure | 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 |
Countries
China
Contacts
Primary ContactHongxuan Wang
Backup ContactWanru Chen
Outcome results
None listed