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/33469828Actively Recruiting
Led by Beijing Tiantan Hospital · Updated on 2024-12-24
1000
Participants Needed
1
Research Sites
156 weeks
Total Duration
Researchers are studying patients with neuroinflammatory and demyelination diseases such as neuromyelitis optica spectrum disorders (NMOSDs), multiple sclerosis (MS), and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). This observational study aims to understand structural and functional changes in the brain, spinal cord, and optic nerve, as well as the inflammatory environment, using advanced magnetic resonance imaging (MRI) technologies. The study evaluates how these changes relate to disease activity and long-term disability. Participants will undergo various MRI scans including double inversion recovery (DIR), diffusion kurtosis imaging (DKI), quantitative susceptibility mapping (QSM), and resting-state functional imaging using 3T MRI, along with T1WI, T2WI, FLAIR, and SWI sequences using 7T MRI. Scans will be done at the acute stage and during follow-ups at 1 month, 6 months, and 1 year. While the study does not restrict treatment methods, many patients receive high-dose intravenous steroid therapy during the acute stage and immunomodulatory therapies like Azathioprine, Mycophenolate Mofetil, or Rituximab during remission. Participants will be monitored through these scheduled MRI scans and clinical assessments including the Expanded Disability Status Scale (EDSS), Timed 25-foot Walk, and visual acuity tests. Researchers will measure brain and spinal cord structural changes and functional changes over time from baseline through follow-up visits. The study involves healthy individuals as controls and spans a follow-up period of one year, allowing detailed observation of disease progression and treatment effects in this group of patients.
CONDITIONS
Clinical and Imaging Cohort of Neuroinflammation Diseases in China (CLUE)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (acute stage)
Participants undergo initial MRI scans of the brain, spinal cord, and optic nerve at the acute stage to assess structural and functional changes related to neuroinflammatory diseases.
1 visit (in-person)
Duration - 1 year
Participants return for follow-up MRI scans and clinical assessments to monitor disease progression and changes in brain and spinal cord structure and function over time.
3 visits (at 1 month, 6 months, and 1 year after acute stage; in-person)
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
Y
Yaou Liu, PhD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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Yun Xu, Yi Ren, Xindi Li...
https://pubmed.ncbi.nlm.nih.gov/33469828