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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02836327
Other study ID # MS and NMOSD-ChinaPLAGH
Secondary ID
Status Recruiting
Phase N/A
First received July 14, 2016
Last updated August 7, 2016
Start date September 2014
Est. completion date September 2021

Study information

Verified date August 2016
Source Chinese PLA General Hospital
Contact Xiaoxiao Ma, M.D.
Phone +86 13323326150
Email 1103483781@qq.com
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Observational

Clinical 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 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.


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 rateļ¼š2ml/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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date September 2021
Est. primary completion date September 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Magnetic Resonance Imaging
Magnetic Resonance Imaging

Locations

Country Name City State
China Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
three months to one year Yes
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