RecruitingNCT04106830

Clinical and Imaging Cohort of Neuroinflammation Diseases in China (CLUE)

Prospective Cohort Study of cLinical and Imaging Patterns of neUroinflammation disEases (CLUE)

Sponsor

Beijing Tiantan Hospital

Enrollment

1,000 participants

Start Date

Jan 1, 2019

Study Type

OBSERVATIONAL

Conditions

MRI Multiple Sclerosis NMO Spectrum Disorder MOGAD

Summary

CLUE is a prospective study to assess structural and functional changes of the brain, spinal cord, and optic nerve, as well as the inflammatory environment in patients with neuroinflammatory and demyelinating diseases. Participants will receive magnetic resonance (MR) techniques including DIR, DKI, QSM, Rs-fMRI, conventional sequences (T1WI/T2WI/FLAIR), and the MR metabolic SPICE sequence, and will be followed up for one year using 3T MRI. In addition, participants will receive a one-time baseline examination including T1WI, T2WI, FLAIR, and SWI sequences on 7T MRI, as well as PET-MRI.

Eligibility

Min Age: 16 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is building a large database in China of patients with brain inflammation and nerve diseases (called neuroinflammatory and demyelinating diseases, such as multiple sclerosis). The goal is to track these patients over time using brain scans and clinical data to better understand these conditions. **You may be eligible if...** - You are between 16 and 75 years old - You have been diagnosed with a neuroinflammatory or demyelinating brain disease - You were seen by doctors around the time your disease first appeared **You may NOT be eligible if...** - You cannot have an MRI scan - You are already enrolled in a blinded clinical trial (where the treatment is kept secret) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntravenous steroid

This study does not limit treatment methods. During the acute stage, patients commonly receive high-dose intravenous methylprednisolone (1g daily for 3-5 days). For severe or refractory cases, plasma exchange (PLEX) or intravenous immunoglobulin (IVIG) may be added. For PACNS, cyclophosphamide is added to steroids as standard induction. During remission, immunomodulatory or immunosuppressive therapies vary by disease: for MS, DMTs such as ocrelizumab or natalizumab; for NMOSD, rituximab (500mg on day 1 and 15, then every 6 months), eculizumab, or satralizumab; for MOGAD, azathioprine, mycophenolate mofetil, or rituximab but only for relapsing patients; for PACNS, azathioprine or mycophenolate mofetil for 12-18 months after cyclophosphamide; for AE, rituximab or cyclophosphamide for refractory cases, with maintenance only for relapsing forms.