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NCT Number: NCT06541626

Sun Yat-Sen Cohort of CNS 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.

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Key information

Conditions

Multiple Sclerosis, MS Acute Disseminated Encephalomyelitis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Central Nervous System Diseases Chronic Disease Clinically Isolated Syndrome Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Demyelinating Disorder Disease Attributes Encephalomyelitis, Acute Disseminated Eye Diseases Immune System Diseases Leukoencephalopathies Multiple Sclerosis Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorders Optic Nerve Diseases Optic Neuritis Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Infectious Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Hongxuan Wang

CONTACT

[email protected]

86-13824498978

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18-65 years with central nervous system idiopathic inflammatory demyelinating diseases (CNS IIDD);
  • 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);
  • Agree to participate in this study and sign the informed consent form.

Exclusion criteria

  • History of tumors or diagnosis of central nervous system tumors;
  • Infectious lesions of the central nervous system;
  • Hereditary, metabolic, toxic, vascular, or traumatic demyelinating diseases of the brain/spinal cord;
  • Non-compliance with treatment and follow-up.

Treatment and study plan

Primary outcomes

  1. Relapse

    Time frame: 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.

  2. Long-term neurological function

    Time frame: 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 outcomes

  1. Long-term neurological function

    Time frame: 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.

  2. Sub-scores of the Expanded Disability Status Scale (EDSS)

    Time frame: 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.

  3. Optical coherence tomography (OCT) of the eyes: retinal nerve fiber layer thickness, macular thickness

    Time frame: Baseline, six months, one year, two years, and average three years

    The thickness is measured by machines by milimetres

  4. Changes in humoral immune markers

    Time frame: 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.

  5. Changes in pathogenic antibody titers

    Time frame: Baseline, six months, one year, two years, and average three years

    Titers of antibodies for MOG, AQP4, MBP, and AFO in iu/l

  6. P100 amplitude of visual evoked potentials

    Time frame: Baseline, six months, one year, two years, and average three years

    Amplitude in volts

  7. P100 latency of visual evoked potentials

    Time frame: Baseline, six months, one year, two years, and average three years

    Latency in seconds

  8. Latency of somatosensory evoked potentials;

    Time frame: Baseline, six months, one year, two years, and average three years

    Latency in seconds

  9. Latency of brainstem auditory evoked potentials;

    Time frame: Baseline, six months, one year, two years, and average three years

    Latency in seconds

  10. Amplitude of somatosensory evoked potentials;

    Time frame: Baseline, six months, one year, two years, and average three years

    Amplitude in volts

  11. Amplitude of brainstem auditory evoked potentials;

    Time frame: Baseline, six months, one year, two years, and average three years

    Amplitude in volts

Other outcomes

  1. Recording of adverse reactions

    Time frame: Baseline, six months, one year, two years, and average three years

  2. Follow-up of common adverse reactions

    Time frame: Baseline, six months, one year, two years, and average three years

Study contacts

Contact information is provided by the study sponsor or research team.

Hongxuan Wang

CONTACT

[email protected]

86+13824498978

Wanru Chen

CONTACT

[email protected]

86+13242800032

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2035
Study completion
2035
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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