Multimodel Magnetic Resonance Imaging (MRI)of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders
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| ClinicalTrials.gov Identifier: NCT02836327 |
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Recruitment Status :
Recruiting
First Posted : July 19, 2016
Last Update Posted : August 9, 2016
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Multiple Sclerosis Neuromyelitis Optica Spectrum Disorders | Other: Magnetic Resonance Imaging |
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 Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Case Control |
| Time Perspective: | Prospective |
| Official Title: | Multimodel MRI to Explore the Pathophysiology of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders |
| Study Start Date : | September 2014 |
| Estimated Primary Completion Date : | September 2019 |
| Estimated Study Completion Date : | September 2021 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Other: Magnetic Resonance Imaging
Magnetic Resonance Imaging |
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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.
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Other: Magnetic Resonance Imaging
Magnetic Resonance Imaging |
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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.
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Other: Magnetic Resonance Imaging
Magnetic Resonance Imaging |
- 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.
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836327
| Contact: Xiaoxiao Ma, M.D. | +86 13323326150 | 1103483781@qq.com | |
| Contact: Jinhao Lyu, M.D. | lvjinhao@hotmail.com |
| China, Beijing | |
| Chinese PLA General Hospital | Recruiting |
| Beijing, Beijing, China, 100853 | |
| Contact: Jinhao Lyu, BS +8613391851857 lvjinhao@hotmail.com | |
| Study Chair: | Xin Lou, M.D.,Ph.D. | Chinese PLA General Hospital |
| Responsible Party: | Xin Lou, Deputy Chief, Chinese PLA General Hospital |
| ClinicalTrials.gov Identifier: | NCT02836327 History of Changes |
| Other Study ID Numbers: |
MS and NMOSD-ChinaPLAGH |
| First Posted: | July 19, 2016 Key Record Dates |
| Last Update Posted: | August 9, 2016 |
| Last Verified: | August 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Keywords provided by Xin Lou, Chinese PLA General Hospital:
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MRI Multiple Sclerosis Neuromyelitis Optica Spectrum Disorders Multimodel |
Additional relevant MeSH terms:
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Disease Sclerosis Multiple Sclerosis Neuromyelitis Optica Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Myelitis, Transverse Optic Neuritis Optic Nerve Diseases Cranial Nerve Diseases Eye Diseases |