The Clinical Features of Combined Central and Peripheral Demyelination

• Conditions: Combined Central and Peripheral Demyelination Disease

• Registration Number: NCT04664647
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12
• Primary Completion: 2020-12
• Study First Submitted: 2020-12-05
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-11
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-16
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Laboratory findings of nodal/paranodal antibodies in blood of patients with CCPD	Day 1 post-gathering information of patients in hospital medical record system	These antibody including anti-neurofascin 155(NF155) et.al.

Secondary Outcome Measures

Name	Time	Method
Demographic characteristics	Day 1 post-gathering information of patients in hospital medical record system	The demographic characteristics of patients with CCPD such as age,sex,and et.al
Neurological symptoms and signs	Day 1 post-gathering information of patients in hospital medical record system	The neurological symptoms and signs of patients with CCPD
Neuroimaging and VEPs findings	Day 1 post-gathering information of patients in hospital medical record system	Neuroimaging and VEPs findings of patients with CCPD
Laboratory findings of blood and cerebrospinal fluid	Day 1 post-gathering information of patients in hospital medical record system	Laboratory findings of blood and cerebrospinal fluid of patients with CCPD such as C reactive protein et.al in blood and protein et.al in cerebrospinal fluid
Nerve conduction study findings	Day 1 post-gathering information of patients in hospital medical record system	Nerve conduction study findings of patients with CCPD