Sun Yat-Sen Cohort of CNS Idiopathic Inflammatory Demyelinating Diseases

Recruiting

• Conditions: Clinically Isolated Syndrome; Neuromyelitis Optica Spectrum Disorders; Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease; Multiple Sclerosis, MS; Acute Disseminated Encephalomyelitis; Demyelinating Disorder

• Registration Number: NCT06541626
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-07-11
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-02
• Last Update Submitted: 2024-08-02
• Study First Posted: 2024-08-07
• Last Update Posted: 2024-08-07
• Primary Completion: 2035-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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
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 amplitude of visual evoked potentials	Baseline, six months, one year, two years, and average three years	Amplitude in volts
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
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.
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

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China