Clinical trial NCT04664647: The Clinical Features of Combined Central and Peripheral Demyelination
Official title: The Clinical Features of Combined Central and Peripheral Demyelination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Combined Central and Peripheral Demyelination Disease
Keywords: CCPD
clinical features
antibody
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have combined central and peripheral demyelination

Brief summary: The investigators conduct this study to clarify the clinical features and to evaluate the prevalence of anti-nodal/paranodal antibodies of patients with combined central and peripheral demyelination (CCPD) .

Detailed description: The investigators will review the clinical manifestation, laboratory test results, electrophysiological examination and neuroimaging findings of patients with CCPD. And we will detect antibodies to aquaporin 4(AQP4), myelin oligodendrocyte glycoprotein (MOG), neurofascin-155 (Nfasc155), neurofascin-186 (Nfasc186), and myelin-associated glycoprotein (MAG) in patients with CCPD.

Eligibility criteria: Inclusion Criteria:

1. T2 high-signal intensity lesions in the brain or spinal cord on MRI, or visual-evoked potentials(VEPs) abnormalities.
2. conduction delay, conduction block, temporal dispersion or F-wave abnormalities, suggesting peripheral demyelinating neuropathy regarding nerve conduction studies (NCS).

Exclusion Criteria:

1. infectious diseases(e.g., human T lymphocyte trophic virus type1-associated myelopathy, syphilis, neuroborreliosis, HIV infection or progressive multifocal leukoencephalopathy)
2. pre-existing inflammatory diseases (e.g., sarcoidosis, Behçet's disease, Sjögren's syndrome, vasculitis or other collagen diseases)
3. mitochondrial disease
4. metabolic/toxic diseases (e.g., vitamin deficiency, amyloidosis, chronic alcoholism, diabetes mellitus or subacute myelo-opticoneuropathy due to clioquinol intoxication
5. cervical spondylotic myelopathy
6. syringomyelia
7. spinocerebellar degeneration
8. multiple myeloma, other tumors
9. inherited diseases (e.g., leucodystrophies)
10. cerebrovascular disease
11. non-specific lesions on T2-weighted MRI (e.g., leucoaraiosis).

Primary outcomes:
measure: Laboratory findings of nodal/paranodal antibodies in blood of patients with CCPD
timeFrame: Day 1 post-gathering information of patients in hospital medical record system
Secondary outcomes:
measure: Demographic characteristics
timeFrame: Day 1 post-gathering information of patients in hospital medical record system
measure: Neurological symptoms and signs
timeFrame: Day 1 post-gathering information of patients in hospital medical record system
measure: Laboratory findings of blood and cerebrospinal fluid
timeFrame: Day 1 post-gathering information of patients in hospital medical record system
measure: Neuroimaging and VEPs findings
timeFrame: Day 1 post-gathering information of patients in hospital medical record system
measure: Nerve conduction study findings
timeFrame: Day 1 post-gathering information of patients in hospital medical record system
Other outcomes:
Locations:
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Junwei Hao
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Wang YQ, Chen H, Zhuang WP, Li HL. The clinical features of combined central and peripheral demyelination in Chinese patients. J Neuroimmunol. 2018 Apr 15;317:32-36. doi: 10.1016/j.jneuroim.2018.02.006. Epub 2018 Feb 9.
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citation: Stathopoulos P, Alexopoulos H, Dalakas MC. Autoimmune antigenic targets at the node of Ranvier in demyelinating disorders. Nat Rev Neurol. 2015 Mar;11(3):143-56. doi: 10.1038/nrneurol.2014.260. Epub 2015 Jan 27.