An observational study in Multiple Sclerosis, NMO Spectrum Disorder and Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by Xuanwu Hospital, Beijing · Observational
The aim of this study is to establish a real-world clinical neuroimmune disease research cohort, to follow up and observe the prognosis of patients with different subtypes and subgroups, and to provide support for the treatment, early warning, and outcome prediction research of neuroimmune diseases.
The purposes of this study are:(1)Establishing a clinical neuroimmune disease research cohort.(2)Collecting the blood, cerebrospinal fluid and other biological samples of the enrolled patients to discover and detect the new neural antibodies, so as to facilitate the diagnosis of related diseases.(3) Conducting in-depth exploration of the Genetic material of patients with neuroimmune diseases and healthy volunteers with second-generation sequencing technology, discovering the pathogenic genes and the mechanism of disease progression.The enrolled patients will be collected Clinical and therapeutic information. Blood and cerebrospinal fluid from the patients will be collected for sequencing analysis and antibody detection. They will also receive the 2-year follow-up with collection of basic clinical information, cognitive function, EDSS score, etc. Healthy volunteers will have their blood collected for sequencing analysis.
Finish the gene sequencing analysis of blood samples from enrolled patients and healthy volunteers to establish the disease gene database and the reference gene database of the healthy population and find the unique expression quantitative trait loci (eQTL) in China, so as to clarify the pathogenic genes and the key mechanism of neuroimmune disease occurrence and development.
Patients and healthy volunteers from China
Patients who diagnosed at Xuanwu Hospital, Capital Medical University with any of the following conditions:
Exclusion Criteria:
Patients diagnosed with neuroimmune diseases by a neurologist.
Other: Data collection and follow-up observation
Healthy adults undergoing medical examinations at the Xuanwu Hospital Physical Examination Center.
Other: Data collection
At the time of enrollment, the patient's biological samples are collected to obtain genetic information. Following enrollment, trained investigators carry out a 2-year follow-up observation through face-to-face, telephone call or online visits. During the follow-up, basic clinical information, laboratory tests, imaging examinations, neurophysiology, clinical classification, medication use, and scale assessments are collected.
Collect demographic and genetic information from healthy volunteers upon enrollment.
Annual recurrence rate
Whether there is recurrence in patients followed up at 12 and 24 months after enrollment
Time frame: At 12 and 24 months after enrollment
Change in Expanded Disability Status Scale scores (EDSS)
Change from baseline in Expanded Disability Status Scale scores (EDSS，range from 0 to 10 points, with a higher score indicating a more severe degree of neurological impairment).
Time frame: At 6,12,18,24 months after enrollment
Change in MRI of head, optic nerve and spinal cord
whether there are New or enlarged lesions in T1WI, T2WI, T2 FLAIR, Sag bravo, DTI, and BOLD MRI of head, optic nerve and spinal cord in neuroimmune disease patients.
Time frame: At 6,12,18,24 months after enrollment
Change in serum and CSF autoimmune antibody status
Collect the patient's serum and cerebrospinal fluid to measure the types and concentrations of autoantibodies. Note any changes compared to the baseline.
Time frame: At 6,12,18,24 months after enrollment
Change in Activity of Daily Living Scale (ADL)
Change from baseline in Activity of Daily Living Scale (ADL, range from 14 to 56 points, with higher scores indicating poorer daily life abilities).
Time frame: At 6,12,18,24 months after enrollment
Change in the relative power spectral density
Change from baseline in the relative power spectral density of the delta and theta bands in patients.
Time frame: At 6,12,18,24 months after enrollment
Changes in Symbol Digit Modalities Test (SDMT)
Change from baseline in Symbol Digit Modalities Test (SDMT, scores range from 0 to 110, with lower scores indicating more severe cognitive impairment).
Time frame: At 6,12,18,24 months after enrollment
Changes in Montreal Cognitive Assessment Test (MoCA)
Change from baseline in Montreal Cognitive Assessment Test (MoCA, scores range from 0 to 30, with lower scores indicating more severe cognitive impairment).
Time frame: At 6,12,18,24 months after enrollment
changes in Mini-Mental Status Exam (MMSE)
Change from baseline in Mini-Mental Status Exam (MMSE, scores range from 0 to 30, with lower scores indicating more severe cognitive impairment.)
Time frame: At 6,12,18,24 months after enrollment
Plan to share: No
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Xuanwu Hospital, Beijing