Combined Central and Peripheral Demyelination Disease Clinical Trial
— CCPDOfficial title:
The Clinical Features of Combined Central and Peripheral Demyelination
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) .
| Status | Not yet recruiting |
| Enrollment | 30 |
| Est. completion date | January 2021 |
| Est. primary completion date | December 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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). |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Xuanwu Hospital, Beijing |
Cortese A, Franciotta D, Alfonsi E, Visigalli N, Zardini E, Diamanti L, Prunetti P, Osera C, Gastaldi M, Berzero G, Pichiecchio A, Piccolo G, Lozza A, Piscosquito G, Salsano E, Ceroni M, Moglia A, Bono G, Pareyson D, Marchioni E. Combined central and peripheral demyelination: Clinical features, diagnostic findings, and treatment. J Neurol Sci. 2016 Apr 15;363:182-7. doi: 10.1016/j.jns.2016.02.022. Epub 2016 Feb 10. — View Citation
Nave KA, Werner HB. Myelination of the nervous system: mechanisms and functions. Annu Rev Cell Dev Biol. 2014;30:503-33. doi: 10.1146/annurev-cellbio-100913-013101. Review. — View Citation
Ogata H, Matsuse D, Yamasaki R, Kawamura N, Matsushita T, Yonekawa T, Hirotani M, Murai H, Kira J. A nationwide survey of combined central and peripheral demyelination in Japan. J Neurol Neurosurg Psychiatry. 2016 Jan;87(1):29-36. doi: 10.1136/jnnp-2014-309831. Epub 2015 Feb 11. — View 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. Review. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Laboratory findings of nodal/paranodal antibodies in blood of patients with CCPD | These antibody including anti-neurofascin 155(NF155) et.al. | Day 1 post-gathering information of patients in hospital medical record system | |
| Secondary | Demographic characteristics | The demographic characteristics of patients with CCPD such as age,sex,and et.al | Day 1 post-gathering information of patients in hospital medical record system | |
| Secondary | Neurological symptoms and signs | The neurological symptoms and signs of patients with CCPD | Day 1 post-gathering information of patients in hospital medical record system | |
| Secondary | Laboratory findings of blood and cerebrospinal fluid | 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 | Day 1 post-gathering information of patients in hospital medical record system | |
| Secondary | Neuroimaging and VEPs findings | Neuroimaging and VEPs findings of patients with CCPD | Day 1 post-gathering information of patients in hospital medical record system | |
| Secondary | Nerve conduction study findings | Nerve conduction study findings of patients with CCPD | Day 1 post-gathering information of patients in hospital medical record system |