Multiple sclerosis
Conditions
Interventions
Disease Group(multiple sclerosis):NA
Disease control group (cerebral small vessel disease):NA
Sponsors
Huashan Hospital,Fudan University
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Disease Group (1).Aged 15 to 65 years old; (2).Meet any one of the following diagnoses (confirmed by two associate chief physicians or above in the Department of Neurology): 1). Multiple Sclerosis (MS): meeting the 2017 or 2024 McDonald Diagnostic Criteria, with clinical classification as Relapsing-Remitting Multiple Sclerosis (RRMS) or Secondary Progressive Multiple Sclerosis (SPMS);2).Clinically Isolated Syndrome (CIS);3).Radiologically Isolated Syndrome (RIS). (3).Signed written informed consent; for minors, consent shall be obtained from their legal guardians. 2. Disease Control Group (1).Aged 15 to 65 years old; (2).Brain lesions on MRI conform to the imaging manifestations of presumed vascular-related white matter hyperintensities (WMH) in the STRIVE-2 criteria: symmetrically distributed hyperintensities in the cerebral hemispheres on T2WI, especially on FLAIR sequence; (3).Other leukoencephalopathies (such as central nervous system vasculitis, migraine, etc.) are excluded based on clinical manifestations and laboratory examinations; (4).Signed informed consent form; 3.Healthy Control Group (1).Aged 15 to 65 years old; (2).Healthy individuals without a history of MS/CIS/RIS and related neurological symptoms; no history of autoimmune diseases, central nervous system diseases, chronic infections and other illnesses. Age distribution is consistent with the case group (individual age difference = 5 years), and gender ratio is matched with the case group; (3).Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. MS Disease Group (1). Meeting the diagnostic criteria for other central nervous system demyelinating diseases such as neuromyelitis optica spectrum disorder (AQP4-IgG positive) and MOG antibody-associated disease (MOG-IgG positive); lesions caused by definite cerebrovascular disease, infection, tumor, metabolic diseases and other etiologies; (2). Presence of vital organ failure such as severe cardiac insufficiency and chronic renal failure; malignant tumors; active autoimmune diseases receiving high-dose immunosuppressive therapy; combined with other neurodegenerative diseases (e.g., Parkinson’s disease, Alzheimer’s disease); (3). Participation in other clinical trials concurrentl (4). Failure to complete the full baseline assessment and expected inability to complete follow-up; (5). Inability to undergo MRI examination due to internal metal implants, claustrophobia and other reasons; (6). Individuals deemed unsuitable for enrollment by the researchers; 2. Disease Control Group (1). Patients judged by two or more experts to have no need to consider cerebral small vessel disease (2). Diseases with monocyte abnormalities, hematological malignancies; (3). Complicated with other neurodegenerative diseases or severe systemic diseases; (4). Other conditions considered unsuitable for enrollment by the researchers; (5). Participation in other clinical trials concurrently; (6). Intolerance to MRI examination. 3. Healthy Control Group (1). Diseases with monocyte abnormalities, hematological malignancies; (2). Complicated with confirmed psychiatric disorders; (3). Complicated with other neurodegenerative diseases or severe systemic diseases; (4). Other conditions considered unsuitable for enrollment by the researchers; (5). Intolerance to MRI examination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MS Radiomic Phenotype; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Neurofilament Light Chain (NfL) Level;Expanded Disability Status Scale (EDSS) Score; | — |
Countries
China
Contacts
Public ContactXiangjun Chen
Huashan Hospital,Fudan Uinversity
Outcome results
None listed