Multiple SclerosisNCT02836327
Multimodel Magnetic Resonance Imaging (MRI)of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders
An observational study of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
To investigate multimodel MRI exploring the pathophysiology of multiple sclerosis and neuromyelitis optica spectrum disorders. The investigators use multimodel MRI to evaluate the extent of blood-brain barrier and white matter fiber tracts destruction , iron deposition and cerebral blood flow of associated regions in… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorders
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Sep 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: patients with multiple sclerosis (according to the 2010 revised Mcdonald criteria) and neuromyelitis optica spectrum disorders (according to the 2015 revised diagnostic criteria)
Who may be able to join
- a diagnosis of neuromyelitis optica spectrum disorders(according to the 2015 revised diagnostic criteria) or relapsing remitting multiple sclerosis(according to the 2010 revised Mcdonald criteria)
- age between 18 years old and 60 years old(concluding 18 years old and 60 years old)
Who cannot join
- common exclusion for MRI such as patients with claustrophobia
- patients with poor imaging quality（Poor imaging quality mainly defined as the image cannot be applied to future analysis on account of severe motion artifacts appeared in conventional MRI and mistakes in the MRI process by accident factors which cannot to be applied to future analysis）
- patients with taking amount of antidepressant recently and with alcoholism and other nervous system diseases
Trial locations and contacts
1 site in 1 country.
Jinhao Lyu, M.D. contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jinhao Lyu, BS, +8613391851857, lvjinhao@hotmail.com
About this study
Official title: Multimodel MRI to Explore the Pathophysiology of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders
To investigate multimodel MRI exploring the pathophysiology of multiple sclerosis and neuromyelitis optica spectrum disorders.
The investigators use multimodel MRI to evaluate the extent of blood-brain barrier and white matter fiber tracts destruction , iron deposition and cerebral blood flow of associated regions in multiple sclerosis and neuromyelitis optica spectrum disorders using contrast-enhanced magnetic resonance imaging , quantitative susceptibility mapping, diffusion tension imaging, and arterial spin labeling with post labeling delay of 2.0 seconds. Transfer constant volume , magnetic susceptibility, cerebral blood flow and fractional anisotropy(FA) value were measured in lesion and normal appearing white matter.
Read the detailed description
Patients:
Patients with multiple sclerosis and neuromyelitis optica spectrum disorders were included. clinical characteristics such as disease duration, expanded disability status scale(EDSS) score, age, associated laboratory examination(autoantibodies directed to aquaporin-4 and oligoclonal bands in serum as well as cerebrospinal fluid)were recorded.
Imaging scan were conducted at admission, six months and one year after admission
Imaging protocols:
MRI scan protocols: T2 weighted image, T1 weighted image, Diffusion weighted image(DWI), fluid-attenuated inversion recovery(FLAIR), dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI) , diffusion tension imaging(DTI) ,quantitative susceptibility mapping(QSM) , arterial spin labeling(ASL) with post labeling delay(PLD) of seconds, sagittal CUBE Fluid Attenuation Inversion Recovery (FLAIR) images, sagittal 3-dimensional Fast Spoiled Gradient Echo(3D-FSPGR).
Contrast agent:
Omniscan 0.1mmol/kg, Inject rate：2ml/s
Imaging evaluation:
Transfer constant volume value measured by DCE-MRI indicates the extent of blood-brain barrier destruction.
Magnetic susceptibility manifests iron deposition in lesions and normal appearing white matter.
Diffusion tension imaging demonstrates the extent of white matter fiber tracts destruction.
Arterial spin labeling(ASL) with post labeling delay(PLD)of seconds shows cerebral blood flow in associated regions.
- Being tested
- Magnetic Resonance Imaging
- Keywords
- MRI, Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorders, Multimodel
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
Magnetic Resonance Imaging
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis | Multiple sclerosis patients confirmed by neurologist according to the 2010 revised Mcdonald criteria without other nervous system diseases.All patients performed magnetic resonance imaging. Receives: Other: Magnetic Resonance Imaging | |
| Neuromyelitis optica spectrum disorders | Neuromyelitis optica spectrum disorders confirmed by neurologist according to the 2015 revised diagnostic criteria without other nervous system diseases.All patients performed magnetic resonance imaging. Receives: Other: Magnetic Resonance Imaging | |
| Health control | Health control is defined as no other nervous system diseases such as ischemic stroke, alzheimer disease and so on. The baseline data(age,education background etc.) is similar to multiple sclerosis and neuromyelitis optica spectrum disorders patients.All participants performed magnetic resonance imaging. Receives: Other: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
The patients will be monitored whether they recured multiple sclerosis and neuromyelitis optica spectrum disorders confirmed by neurologist and conventional MRI.
Clinical suspicious signs of recurrence : visual loss,urination and defecation function disturbance and so on.
Conventional MRI: there are new lesions or the lesions show high signal on diffusion weighted images or enhancement on post contrast enhanced images.
Measured: three months to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startSep 2014
- Primary completionSep 2019 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Lou, Chinese PLA General Hospital
- Investigators
- Xin Lou, M.D.,Ph.D., Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836327
- Sponsor's protocol ID
- MS and NMOSD-ChinaPLAGH
- Status last verified
- Aug 2016
- First submitted
- 14 Jul 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodel MRI to Explore the Pathophysiology of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02836327
- Acronym / sponsor ID
- MS and NMOSD-ChinaPLAGH
- Keywords
- MRI, Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorders, Multimodel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 19 Jul 2016 (estimated)
- 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.
To investigate multimodel MRI exploring the pathophysiology of multiple sclerosis and neuromyelitis optica spectrum disorders.
The investigators use multimodel MRI to evaluate the extent of blood-brain barrier and white matter fiber tracts destruction , iron deposition and cerebral blood flow of associated regions in multiple sclerosis and neuromyelitis optica spectrum disorders using contrast-enhanced magnetic resonance imaging , quantitative susceptibility mapping, diffusion tension imaging, and arterial spin labeling with post labeling delay of 2.0 seconds. Transfer constant volume , magnetic susceptibility, cerebral blood flow and fractional anisotropy(FA) value were measured in lesion and normal appearing white matter.
Detailed description
Patients:
Patients with multiple sclerosis and neuromyelitis optica spectrum disorders were included. clinical characteristics such as disease duration, expanded disability status scale(EDSS) score, age, associated laboratory examination(autoantibodies directed to aquaporin-4 and oligoclonal bands in serum as well as cerebrospinal fluid)were recorded.
Imaging scan were conducted at admission, six months and one year after admission
Imaging protocols:
MRI scan protocols: T2 weighted image, T1 weighted image, Diffusion weighted image(DWI), fluid-attenuated inversion recovery(FLAIR), dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI) , diffusion tension imaging(DTI) ,quantitative susceptibility mapping(QSM) , arterial spin labeling(ASL) with post labeling delay(PLD) of seconds, sagittal CUBE Fluid Attenuation Inversion Recovery (FLAIR) images, sagittal 3-dimensional Fast Spoiled Gradient Echo(3D-FSPGR).
Contrast agent:
Omniscan 0.1mmol/kg, Inject rate：2ml/s
Imaging evaluation:
Transfer constant volume value measured by DCE-MRI indicates the extent of blood-brain barrier destruction.
Magnetic susceptibility manifests iron deposition in lesions and normal appearing white matter.
Diffusion tension imaging demonstrates the extent of white matter fiber tracts destruction.
Arterial spin labeling(ASL) with post labeling delay(PLD)of seconds shows cerebral blood flow in associated regions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis | – | Other: Magnetic Resonance ImagingMultiple sclerosis patients confirmed by neurologist according to the 2010 revised Mcdonald criteria without other nervous system diseases.All patients performed magnetic resonance imaging. |
| Neuromyelitis optica spectrum disorders | – | Other: Magnetic Resonance ImagingNeuromyelitis optica spectrum disorders confirmed by neurologist according to the 2015 revised diagnostic criteria without other nervous system diseases.All patients performed magnetic resonance imaging. |
| Health control | – | Other: Magnetic Resonance ImagingHealth control is defined as no other nervous system diseases such as ischemic stroke, alzheimer disease and so on. The baseline data(age,education background etc.) is similar to multiple sclerosis and neuromyelitis optica spectrum disorders patients.All participants performed magnetic resonance imaging. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients with multiple sclerosis (according to the 2010 revised Mcdonald criteria) and neuromyelitis optica spectrum disorders (according to the 2015 revised diagnostic criteria)
Key inclusion criteria (2 listed)
- a diagnosis of neuromyelitis optica spectrum disorders(according to the 2015 revised diagnostic criteria) or relapsing remitting multiple sclerosis(according to the 2010 revised Mcdonald criteria)
- age between 18 years old and 60 years old(concluding 18 years old and 60 years old)
Key exclusion criteria (3 listed)
- common exclusion for MRI such as patients with claustrophobia
- patients with poor imaging quality（Poor imaging quality mainly defined as the image cannot be applied to future analysis on account of severe motion artifacts appeared in conventional MRI and mistakes in the MRI process by accident factors which cannot to be applied to future analysis）
- patients with taking amount of antidepressant recently and with alcoholism and other nervous system diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingMagnetic Resonance Imaging | Other | Health control, Multiple sclerosis, Neuromyelitis optica spectrum disorders |
Primary outcome
Recurrence
Time frame: three months to one year
The patients will be monitored whether they recured multiple sclerosis and neuromyelitis optica spectrum disorders confirmed by neurologist and conventional MRI. Clinical suspicious signs of recurrence : visual loss,urination and defecation function disturbance and so on. Conventional MRI: there are new lesions or the lesions show high signal on diffusion weighted images or enhancement on post contrast enhanced images.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
Jinhao Lyu, M.D. contact
Xin Lou, M.D.,Ph.D. study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders, run by Chinese PLA General Hospital at 1 site in China.
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 3 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 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Xiaoxiao Ma, M.D. (+86 13323326150, 1103483781@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: three months to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2016.