Sun Yat-Sen Cohort of CNS Idiopathic Inflammatory Demyelinating Diseases

Sun Yat-Sen Prospective Cohort Study of Central Nervous System Idiopathic Inflammatory Demyelinating Diseases

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Hongxuan Wang; Phone Number: 86+13824498978; Email: wanghx8@mail.sysu.edu.cn
• Study Contact Backup: Name: Wanru Chen; Phone Number: 86+13242800032; Email: chenwr23@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital
      • Contact: Hongxuan Wang; Phone Number: 86-13824498978; Email: wanghx8@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
MS; Diagnosis meets the 2017 McDonald diagnostic criteria, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus.
NMOSD; Diagnosis meets the 2015 IPND diagnostic panel standards, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus.
MOGAD; Diagnosis meets the 2023 international expert panel recommended standards, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus.
ADEM; Diagnosis meets the diagnostic criteria for ADEM
CIS; Diagnosis meets the 2017 McDonald diagnostic criteria, receive the recommended diagnosis and treatment plans from current international and national guidelines or expert consensus.
undefined CNS IIDD; First occurrence of CNS inflammatory demyelinating event, not yet diagnosable as MS, NMOSD, MOGAD, ADEM, or other definitive types of central nervous system demyelinating diseases, with symptoms and signs lasting more than 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse	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.	Through study completion, an average of 5 years
Long-term neurological function	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.	Through study completion, an average of 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term neurological function	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.	Baseline, six months, one year, two years, and average three years
Sub-scores of the Expanded Disability Status Scale (EDSS)	EDSS sub-score ranges from 0 to 5 or 6, with 0 indicating a normal healthy state, higher scores indicating worse neurological functions.	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	The thickness is measured by machines by milimetres	Baseline, six months, one year, two years, and average three years
Changes in humoral immune markers	The levels of neurofilament light chain (NfL), soluble GFAP, soluble TREM2, and other potential biomarkers are measured in g/ml.	Baseline, six months, one year, two years, and average three years
Changes in pathogenic antibody titers	Titers of antibodies for MOG, AQP4, MBP, and AFO in iu/l	Baseline, six months, one year, two years, and average three years
P100 amplitude of visual evoked potentials	Amplitude in volts	Baseline, six months, one year, two years, and average three years
P100 latency of visual evoked potentials	Latency in seconds	Baseline, six months, one year, two years, and average three years
Latency of somatosensory evoked potentials;	Latency in seconds	Baseline, six months, one year, two years, and average three years
Latency of brainstem auditory evoked potentials;	Latency in seconds	Baseline, six months, one year, two years, and average three years
Amplitude of somatosensory evoked potentials;	Amplitude in volts	Baseline, six months, one year, two years, and average three years
Amplitude of brainstem auditory evoked potentials;	Amplitude in volts	Baseline, six months, one year, two years, and average three years

Other Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: follow-up; CNS IIDD
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Eye Diseases; Disease Attributes; Central Nervous System Infections; Optic Nerve Diseases; Cranial Nerve Diseases; Myelitis, Transverse; Optic Neuritis; Leukoencephalopathies; Chronic Disease; Neuroinflammatory Diseases; Post-Infectious Disorders; Multiple Sclerosis; Neuromyelitis Optica; Demyelinating Diseases; Encephalomyelitis; Encephalomyelitis, Acute Disseminated
• Other Study ID Numbers: SYSKY-2024-109-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No