Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

MRI,Gene And Cognitive Performance Study of Patients With Cerebral White Matter Lesions(WMLs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276976
Recruitment Status : Unknown
Verified December 2015 by Wei Wang, Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : October 28, 2014
Last Update Posted : December 14, 2015
Sponsor:
Information provided by (Responsible Party):
Wei Wang, Huazhong University of Science and Technology

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is:1)to observe topological organization in brain structural and functional networks in cerebral white matter lesion patients and to evaluate the association between impairment of cognitive function and cerebral structural and functional networks in those patients;2)to indicate the role of genetic factors in the occurrence and prognosis of cerebral white matter lesions

Condition or disease
Cerebral White Matter Lesions

Detailed Description:
100 patients with cerebral white matter lesions and 100 normal controls will be observed. All of them will receive MRI scan(T1WI,T2WI,T2flair,MRA,SWI,ASL,DTI and fMRI) and the assessment of the neuropsychological function (MMSE,Auditory verbal memory test,Trail-making test-A and -B,Symbol digit modalities test,Digit span test,Clock drawing test,HAMD) intending to analyse topological organization in brain structural and functional networks in cerebral white matter lesion patients and to evaluate the association between impairment of cognitive function and cerebral structural and functional networks in those patients.Furthermore,DNA will be extracted from the blood sample of all participates to perform High-throughput sequencing. MRI scan and neuropsychological function assessment will be performed repeatedly after 1,3 and 5 years.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: MRI,Gene And Cognitive Performance Study of Patients With Cerebral White Matter Lesions
Study Start Date : March 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
cerebral white matter lesions
patients with MRI confirmed cerebral white matter lesions
healthy volunteers
healthy volunteers 1:1 matched by age,sex and education years


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. MRI and cognitive function scale [ Time Frame: up to 5 years after first assessment ]

Biospecimen Retention:   Samples With DNA
DNA extracted from whole blood sample

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with cerebral white matter lesions
Criteria

Inclusion Criteria:

  • MRI diagnosis of cerebral white matter lesions Must be able to measure his(her) neuropsychologic function No severe stroke history and no physical disability Patients aged 40 to 85 Based on China's relevant laws, the patient himself agreed to participate in this study, a good compliance.Patients himself/herself must sign informed consent moreover

Exclusion Criteria:

  • Unable to undergo examinations due to disturbances of consciousness or medical conditions Serious complications including severe heart failure, hepatic dysfunction, renal insufficiency,or shock AD,Parkinson's disease, malignant tumor, MS and other autoimmune diseases toxic and metabolic encephalopathy cerebral white matter lesions caused by CADASIL and other confirmed monogenic disease
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02276976


Contacts
Layout table for location contacts
Contact: Wei Wang, Doctor 86-027-8366-3648 tianyalinghu@126.com

Locations
Layout table for location information
China, Hubei
Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Wei Wang, Doctor    86-027-8366-3648    tianyalinghu@126.com   
Principal Investigator: Wei Wang, Doctor         
Sub-Investigator: Wenhao Zhu, Master         
Sponsors and Collaborators
Wei Wang
Investigators
Layout table for investigator information
Principal Investigator: Wei Wang, Doctor Tongji Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Wei Wang, professor, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02276976    
Other Study ID Numbers: 2013BCB022
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: December 14, 2015
Last Verified: December 2015
Keywords provided by Wei Wang, Huazhong University of Science and Technology:
crebral white matter lesions
brain networks
MRI
DTI
 fMRI
cognitive impairment
gene