Combined Central and Peripheral Demyelination DiseaseCCPDNCT04664647
The Clinical Features of Combined Central and Peripheral Demyelination
An observational study of Combined Central and Peripheral Demyelination Disease, run by Xuanwu Hospital, Beijing.
Trial 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) . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Combined Central and Peripheral Demyelination Disease
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have combined central and peripheral demyelination
Who may be able to join
- T2 high-signal intensity lesions in the brain or spinal cord on MRI, or visual-evoked potentials(VEPs) abnormalities.
- conduction delay, conduction block, temporal dispersion or F-wave abnormalities, suggesting peripheral demyelinating neuropathy regarding nerve conduction studies (NCS).
Who cannot join
- infectious diseases(e.g., human T lymphocyte trophic virus type1-associated myelopathy, syphilis, neuroborreliosis, HIV infection or progressive multifocal leukoencephalopathy)
- pre-existing inflammatory diseases (e.g., sarcoidosis, Behçet's disease, Sjögren's syndrome, vasculitis or other collagen diseases)
- mitochondrial disease
- metabolic/toxic diseases (e.g., vitamin deficiency, amyloidosis, chronic alcoholism, diabetes mellitus or subacute myelo-opticoneuropathy due to clioquinol intoxication
- cervical spondylotic myelopathy
- syringomyelia
Show all 11Show fewer
- spinocerebellar degeneration
- multiple myeloma, other tumors
- inherited diseases (e.g., leucodystrophies)
- cerebrovascular disease
- non-specific lesions on T2-weighted MRI (e.g., leucoaraiosis).
Trial locations and contacts
No sites are listed yet.
About this study
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) .
Read the 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.
- Keywords
- CCPD, clinical features, antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with CCPD | Inclusion criteria： 1. Criteria for central nervous system involvement: T2 high-signal intensity lesions in the brain, or spinal cord on MRI, or visual-evoked potentials(VEPs) abnormalities. 2. Criteria for peripheral nervous system involvement: conduction delay, conduction block, temporal dispersion or F-wave abnormalities, suggesting peripheral demyelinating neuropathy regarding nerve conduction studies (NCS). In the present study, it was compulsory for at least two nerves between the median, ulnar, tibial and peroneal nerves to have abnormal findings indicating demyelination. Exclusion criterion: Secondary demyelinating diseases or changes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory findings of nodal/paranodal antibodies in blood of patients with CCPD
These antibody including anti-neurofascin 155(NF155) et.al.
Measured: Day 1 post-gathering information of patients in hospital medical record system
Secondary outcomes (5)
Demographic characteristics
The demographic characteristics of patients with CCPD such as age,sex,and et.al
Measured: Day 1 post-gathering information of patients in hospital medical record system
Neurological symptoms and signs
The neurological symptoms and signs of patients with CCPD
Measured: Day 1 post-gathering information of patients in hospital medical record system
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
Measured: Day 1 post-gathering information of patients in hospital medical record system
Neuroimaging and VEPs findings
Neuroimaging and VEPs findings of patients with CCPD
Measured: Day 1 post-gathering information of patients in hospital medical record system
Nerve conduction study findings
Nerve conduction study findings of patients with CCPD
Measured: Day 1 post-gathering information of patients in hospital medical record system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Combined Central and Peripheral Demyelination DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, haojunwei, Xuanwu Hospital, Beijing
- Investigators
- Junwei Hao, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664647
- Sponsor's protocol ID
- haojunwei1
- Acronym
- CCPD
- Status last verified
- Dec 2020
- First submitted
- 5 Dec 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27000248Ogata 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.
PubMed 25673872Wang 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.
PubMed 29501083Nave 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.
PubMed 25288117Stathopoulos 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.
PubMed 25623793
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Features of Combined Central and Peripheral Demyelination
- ClinicalTrials.gov ID
- NCT04664647
- Acronym / sponsor ID
- CCPD / haojunwei1
- Keywords
- CCPD, clinical features, antibody
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CCPD | – | –Inclusion criteria： 1. Criteria for central nervous system involvement: T2 high-signal intensity lesions in the brain, or spinal cord on MRI, or visual-evoked potentials(VEPs) abnormalities. 2. Criteria for peripheral nervous system involvement: conduction delay, conduction block, temporal dispersion or F-wave abnormalities, suggesting peripheral demyelinating neuropathy regarding nerve conduction studies (NCS). In the present study, it was compulsory for at least two nerves between the median, ulnar, tibial and peroneal nerves to have abnormal findings indicating demyelination. Exclusion criterion: Secondary demyelinating diseases or changes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have combined central and peripheral demyelination
Key inclusion criteria (2 listed)
- T2 high-signal intensity lesions in the brain or spinal cord on MRI, or visual-evoked potentials(VEPs) abnormalities.
- conduction delay, conduction block, temporal dispersion or F-wave abnormalities, suggesting peripheral demyelinating neuropathy regarding nerve conduction studies (NCS).
Key exclusion criteria (11 listed)
- infectious diseases(e.g., human T lymphocyte trophic virus type1-associated myelopathy, syphilis, neuroborreliosis, HIV infection or progressive multifocal leukoencephalopathy)
- pre-existing inflammatory diseases (e.g., sarcoidosis, Behçet's disease, Sjögren's syndrome, vasculitis or other collagen diseases)
- mitochondrial disease
- metabolic/toxic diseases (e.g., vitamin deficiency, amyloidosis, chronic alcoholism, diabetes mellitus or subacute myelo-opticoneuropathy due to clioquinol intoxication
- cervical spondylotic myelopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Laboratory findings of nodal/paranodal antibodies in blood of patients with CCPD
Time frame: Day 1 post-gathering information of patients in hospital medical record system
These antibody including anti-neurofascin 155(NF155) et.al.
5 secondary outcomes
Demographic characteristics
Time frame: Day 1 post-gathering information of patients in hospital medical record system
Neurological symptoms and signs
Time frame: Day 1 post-gathering information of patients in hospital medical record system
Laboratory findings of blood and cerebrospinal fluid
Time frame: Day 1 post-gathering information of patients in hospital medical record system
Neuroimaging and VEPs findings
Time frame: Day 1 post-gathering information of patients in hospital medical record system
Nerve conduction study findings
Time frame: Day 1 post-gathering information of patients in hospital medical record system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Background: PubMed 27000248Cortese 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.
- Background: PubMed 25673872Ogata 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.
- Background: PubMed 29501083Wang 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.
- Background: PubMed 25288117Nave 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.
- Background: PubMed 25623793Stathopoulos 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Junwei Hao principal investigator
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
An observational study of Combined Central and Peripheral Demyelination Disease, run by Xuanwu Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junwei Hao, MD,PhD (010-83199088, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory findings of nodal/paranodal antibodies in blood of patients with CCPD (time frame: Day 1 post-gathering information of patients in hospital medical record system). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04664647, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.