Clinical trial NCT06541626: Sun Yat-Sen Cohort of CNS Idiopathic Inflammatory Demyelinating Diseases
Official title: Sun Yat-Sen Prospective Cohort Study of Central Nervous System Idiopathic Inflammatory Demyelinating Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis, MS
Neuromyelitis Optica Spectrum Disorders
Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease
Acute Disseminated Encephalomyelitis
Clinically Isolated Syndrome
Demyelinating Disorder
Keywords: CNS IIDD
follow-up
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are aged between 18 and 65 years and diagnosed with central nervous system idiopathic inflammatory demyelinating diseases

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Relapse
timeFrame: Through study completion, an average of 5 years
measure: Long-term neurological function
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
measure: Long-term neurological function
timeFrame: Baseline, six months, one year, two years, and average three years
measure: Sub-scores of the Expanded Disability Status Scale (EDSS)
timeFrame: Baseline, six months, one year, two years, and average three years
measure: Optical coherence tomography (OCT) of the eyes: retinal nerve fiber layer thickness, macular thickness
timeFrame: Baseline, six months, one year, two years, and average three years
measure: Changes in humoral immune markers
timeFrame: Baseline, six months, one year, two years, and average three years
measure: Changes in pathogenic antibody titers
timeFrame: Baseline, six months, one year, two years, and average three years
measure: P100 amplitude of visual evoked potentials
timeFrame: Baseline, six months, one year, two years, and average three years
measure: P100 latency of visual evoked potentials
timeFrame: Baseline, six months, one year, two years, and average three years
measure: Latency of somatosensory evoked potentials;
timeFrame: Baseline, six months, one year, two years, and average three years
measure: Latency of brainstem auditory evoked potentials;
timeFrame: Baseline, six months, one year, two years, and average three years
measure: Amplitude of somatosensory evoked potentials;
timeFrame: Baseline, six months, one year, two years, and average three years
measure: Amplitude of brainstem auditory evoked potentials;
timeFrame: Baseline, six months, one year, two years, and average three years
Other outcomes:
measure: Recording of adverse reactions
timeFrame: Baseline, six months, one year, two years, and average three years
measure: Follow-up of common adverse reactions
timeFrame: Baseline, six months, one year, two years, and average three years
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
Study officials:
References: