Multiple Sclerosis Clinical Trial
— NIDBaseOfficial title:
National, Multicentric Registry Study on Neuroimmunological Diseases in China
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.
Status | Recruiting |
Enrollment | 7000 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients who diagnosed at Xuanwu Hospital, Capital Medical University with any of the following conditions: - Multiple Sclerosis (the criteria followed the Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria) - NMO Spectrum Disorder (the criteria followed the Diagnosis and Treatment Guidelines for Optic Neuromyelitis Spectrum Disorders in China 2016) - Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (the criteria followed the Consensus of Chinese Experts on Diagnosis and Treatment of Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody-Associated Diseases) - Myasthenia Gravis (the criteria followed the Guidelines for the Diagnosis and Treatment of Myasthenia Gravis in China 2020) - Autoimmune Encephalitis (the criteria followed the China Expert Consensus on Diagnosis and Treatment of Autoimmune Encephalitis 2017) - Acute Disseminated Encephalomyelitis (the criteria are based on the article titled "Acute disseminated encephalomyelitis" 2007). - Healthy adults who underwent a physical examination at the Physical Examination Center of Xuanwu Hospital, Capital Medical University Exclusion Criteria: - Women during pregnancy or lactation. - Patients with other neurological diseases or serious mental diseases. - Patients with serious liver and kidney function or other important organ dysfunction. - Unable to cooperate with follow-up work and venous blood collection due to poor compliance of patients or healthy volunteers, or incomplete clinical and imaging data. |
Country | Name | City | State |
---|---|---|---|
China | Xuanwu Hospital ,Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Annual recurrence rate | Whether there is recurrence in patients followed up at 12 and 24 months after enrollment | At 12 and 24 months after enrollment | |
Secondary | 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). | At 6,12,18,24 months after enrollment | |
Secondary | 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. | At 6,12,18,24 months after enrollment | |
Secondary | 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. | At 6,12,18,24 months after enrollment | |
Secondary | 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). | At 6,12,18,24 months after enrollment | |
Secondary | Change in the relative power spectral density | Change from baseline in the relative power spectral density of the delta and theta bands in patients. | At 6,12,18,24 months after enrollment | |
Secondary | 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). | At 6,12,18,24 months after enrollment | |
Secondary | 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). | At 6,12,18,24 months after enrollment | |
Secondary | 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.) | At 6,12,18,24 months after enrollment |
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