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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

MRIMultiple SclerosisNMO Spectrum DisorderMOGAD

Summary

CLUE is a prospective study to determine structural and functional changes of brain and spinal cord, as well as the inflammatory environment in patients with neuroinflammatory and demyelination disease. Participants will receive new magnetic resonance (MR) technics including double inversion recovery (DIR) imaging diffusion kurtosis imaging (DKI), quantitative susceptibility mapping (QSM) and resting-state functional imaging and follow up for one year using 3T MRI. In addition, participants will receive T1WI, T2WI, FLAIR and SWI sequences on 7T 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.patients commonly use high-dose intravenous steroid therapy (HD-S) during acute stage. The HD-S treatment course referred to intravenous administration of 1 g of glucocorticoid daily for 3 consecutive days and continuous dose 240 mg reduction for 60mg oral administration. Immunomodulatory therapies are necessary for the remission stage. The treatment methods include: Azathioprine (start at 50 mg per day, add 50 mg per week to 2 mg/kg.d); Mycophenolate Mofetil (The initial dose was 0.25g bid, add 0.5g per week to 0.75g bid); and Rituximab (500 mg on the 1st day, the 15th day, then 500mg per half year).

Locations(1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

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NCT04106830

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