RecruitingEarly (CIS/RIS)NCT06541626

What it found

Still running

No result yet.

What it measured

Main measures

  • Relapse

    Through study completion, an average of 5 years

    Disability progressionRelapsesMRI lesions
  • Long-term neurological function

    Through study completion, an average of 5 years

    Disability progression

Other measures (11)

  • Long-term neurological function

    Baseline, six months, one year, two years, and average three years

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

    Baseline, six months, one year, two years, and average three years

    Disability progression
  • 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

    Retina scans (OCT)
  • Changes in humoral immune markers

    Baseline, six months, one year, two years, and average three years

    Blood or spinal fluid markers
  • Changes in pathogenic antibody titers

    Baseline, six months, one year, two years, and average three years

    Immune response
  • P100 amplitude of visual evoked potentials

    Baseline, six months, one year, two years, and average three years

    Myelin repair
  • P100 latency of visual evoked potentials

    Baseline, six months, one year, two years, and average three years

    Myelin repair
  • Latency of somatosensory evoked potentials;

    Baseline, six months, one year, two years, and average three years

    Myelin repair
  • Latency of brainstem auditory evoked potentials;

    Baseline, six months, one year, two years, and average three years

    Myelin repair
  • Amplitude of somatosensory evoked potentials;

    Baseline, six months, one year, two years, and average three years

    Myelin repair

Who could take part

Early (CIS/RIS) · 18 to 65

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Jan 2024

      2. Main results due

        Dec 2035

      3. Finished

        Dec 2035

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