Clinical and Imaging Cohort of Neuroinflammation Diseases in China (CLUE)
Prospective Cohort Study of CLinical and Imaging Patterns of NeUroinflammation DisEases (CLUE)
Beijing Tiantan Hospital
1,000 participants
Jan 1, 2019
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- Diagnosis of neuroinflammatory and demyelination disease
- Availability of demographic and clinical data at the time disease onset
- Informed written consent obtained from the patient, and/or patient's parent(s), and/or legal representative. Assent, if old enough to grant, will be obtained from all patients under the age of 16 years.
Exclusion Criteria2
- Patients for whom MRI is contra-indicated
- Patients included in an ongoing clinical trial where the product is blinded
Interventions
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)
View Full Details on ClinicalTrials.gov
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NCT04106830