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Multimodel Magnetic Resonance Imaging (MRI)of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT02836327
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Xin Lou, Chinese PLA General Hospital

Study Description
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Brief 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 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

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
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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

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: Magnetic Resonance Imaging
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.
 Other: Magnetic Resonance Imaging
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.
 Other: Magnetic Resonance Imaging
Magnetic Resonance Imaging


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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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
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)
Criteria

Inclusion Criteria:

  1. 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)
  2. age between 18 years old and 60 years old(concluding 18 years old and 60 years old)

Exclusion Criteria:

  1. common exclusion for MRI such as patients with claustrophobia
  2. 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）
  3. patients with taking amount of antidepressant recently and with alcoholism and other nervous system diseases
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Xiaoxiao Ma, M.D. +86 13323326150 1103483781@qq.com
Contact: Jinhao Lyu, M.D. lvjinhao@hotmail.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Jinhao Lyu, BS    +8613391851857    lvjinhao@hotmail.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Study Chair: Xin Lou, M.D.,Ph.D. Chinese PLA General Hospital
More Information
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Responsible Party: Xin Lou, Deputy Chief, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02836327    
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:
MRI
Multiple Sclerosis
Neuromyelitis Optica Spectrum Disorders
Multimodel
Additional relevant MeSH terms:
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Multiple Sclerosis
Neuromyelitis Optica
Disease
Sclerosis
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