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

NCT ID: NCT02836327

Last Updated: 2016-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis Neuromyelitis Optica Spectrum Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Magnetic Resonance Imaging

Intervention Type 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.

Magnetic Resonance Imaging

Intervention Type 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.

Magnetic Resonance Imaging

Intervention Type OTHER

Magnetic Resonance Imaging

Interventions

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Magnetic Resonance Imaging

Magnetic Resonance Imaging

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xin Lou

Deputy Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xin Lou, M.D.,Ph.D.

Role: STUDY_CHAIR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoxiao Ma, M.D.

Role: CONTACT

+86 13323326150

Jinhao Lyu, M.D.

Role: CONTACT

Facility Contacts

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Jinhao Lyu, BS

Role: primary

+8613391851857

Other Identifiers

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MS and NMOSD-ChinaPLAGH

Identifier Type: -

Identifier Source: org_study_id

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