Persistently Gadolinium-Enhancing Lesion Is a Predictor of Poor Prognosis in NMOSD Attack: a Clinical Trial.
Yun Xu, Yi Ren, Xindi Li...
https://pubmed.ncbi.nlm.nih.gov/33469828/Actively Recruiting
Led by Beijing Tiantan Hospital · Updated on 2026-06-15
1000
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are investigating structural and functional changes in the brain, spinal cord, and optic nerve, as well as inflammation in patients with neuroinflammatory and demyelinating diseases such as clinical isolated syndrome, multiple sclerosis, neuromyelitis optica spectrum disorders, and myelin oligodendrocyte glycoprotein antibody-associated disorders. This observational study uses advanced MRI and PET-MRI to better understand the underlying disease mechanisms and progression, focusing on both acute and chronic stages. The study includes healthy controls and other immune-mediated diseases for comparison. Participants will undergo multiple magnetic resonance imaging scans at the acute stage and follow-up visits at 3 months, 6 months, and 1 year using 3T MRI, as well as a one-time baseline examination with 7T MRI and PET-MRI. The imaging techniques include DIR, DKI, QSM, resting-state fMRI, and metabolic SPICE sequences, which provide detailed information on brain metabolites and tissue properties. Treatment methods are not restricted and may include intravenous steroids, plasma exchange, immunoglobulin, and various immunomodulatory therapies depending on the disease and stage. Throughout the study, participants will be monitored with MRI scans to assess changes over time in brain and spinal cord structure and function. Clinical assessments include disability status, functional systems, walking speed, and visual acuity measured at baseline, 6 months, and 1 year. The study aims to capture detailed imaging and clinical data to understand disease activity and progression. Participants will be followed for one year, with safety and disease activity monitored during this period.
CONDITIONS
Clinical and Imaging Cohort of Neuroinflammation Diseases in China (CLUE)
Y
Yaou Liu, PhD
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Beijing Tiantan Hospital
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 year
Participants undergo MRI and PET-MRI scans at baseline and follow-up visits at 3 months, 6 months, and 1 year to assess brain and spinal cord changes and clinical status.
Baseline and 3 follow-up visits
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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Yun Xu, Yi Ren, Xindi Li...
https://pubmed.ncbi.nlm.nih.gov/33469828/Beijing Tiantan Hospital
Lead Sponsor