National, Multicentric Registry Study on Neuroimmunological Diseases in China
- Conditions
- NMO Spectrum DisorderAutoimmune EncephalitisMultiple SclerosisMyelin Oligodendrocyte Glycoprotein Antibody-associated DiseaseMyasthenia GravisAcute Disseminated Encephalomyelitis
- Interventions
- Other: Data collection and follow-up observationOther: Data collection
- Registration Number
- NCT06443333
- Lead Sponsor
- Xuanwu Hospital, Beijing
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 7000
-
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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description neuroimmune diseases patient Data collection and follow-up observation Patients diagnosed with neuroimmune diseases by a neurologist. Health Volunteers Data collection Healthy adults undergoing medical examinations at the Xuanwu Hospital Physical Examination Center.
- Primary Outcome Measures
Name Time Method Annual recurrence rate At 12 and 24 months after enrollment Whether there is recurrence in patients followed up at 12 and 24 months after enrollment
- Secondary Outcome Measures
Name Time Method Change in serum and CSF autoimmune antibody status At 6,12,18,24 months after enrollment Collect the patient's serum and cerebrospinal fluid to measure the types and concentrations of autoantibodies. Note any changes compared to the baseline.
Change in Expanded Disability Status Scale scores (EDSS) At 6,12,18,24 months after enrollment 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).
Change in MRI of head, optic nerve and spinal cord At 6,12,18,24 months after enrollment 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.
Change in the relative power spectral density At 6,12,18,24 months after enrollment Change from baseline in the relative power spectral density of the delta and theta bands in patients.
Change in Activity of Daily Living Scale (ADL) At 6,12,18,24 months after enrollment Change from baseline in Activity of Daily Living Scale (ADL, range from 14 to 56 points, with higher scores indicating poorer daily life abilities).
Changes in Symbol Digit Modalities Test (SDMT) At 6,12,18,24 months after enrollment Change from baseline in Symbol Digit Modalities Test (SDMT, scores range from 0 to 110, with lower scores indicating more severe cognitive impairment).
Changes in Montreal Cognitive Assessment Test (MoCA) At 6,12,18,24 months after enrollment Change from baseline in Montreal Cognitive Assessment Test (MoCA, scores range from 0 to 30, with lower scores indicating more severe cognitive impairment).
changes in Mini-Mental Status Exam (MMSE) At 6,12,18,24 months after enrollment Change from baseline in Mini-Mental Status Exam (MMSE, scores range from 0 to 30, with lower scores indicating more severe cognitive impairment.)
Trial Locations
- Locations (1)
Xuanwu Hospital ,Capital Medical University
🇨🇳Beijing, Beijing, China