- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02276976
MRI,Gene And Cognitive Performance Study of Patients With Cerebral White Matter Lesions(WMLs)
December 11, 2015 updated by: Wei Wang
MRI,Gene And Cognitive Performance Study of Patients With Cerebral White Matter Lesions
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
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wei Wang, Doctor
- Phone Number: 86-027-8366-3648
- Email: tianyalinghu@126.com
Study Locations
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Hubei
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Wuhan, Hubei, China, 430030
- Recruiting
- Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology
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Contact:
- Wei Wang, Doctor
- Phone Number: 86-027-8366-3648
- Email: tianyalinghu@126.com
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Sub-Investigator:
- Wenhao Zhu, Master
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with cerebral white matter lesions
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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cerebral white matter lesions
patients with MRI confirmed cerebral white matter lesions
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healthy volunteers
healthy volunteers 1:1 matched by age,sex and education years
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MRI and cognitive function scale
Time Frame: up to 5 years after first assessment
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up to 5 years after first assessment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2014
Primary Completion (Anticipated)
February 1, 2016
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
October 25, 2014
First Submitted That Met QC Criteria
October 27, 2014
First Posted (Estimate)
October 28, 2014
Study Record Updates
Last Update Posted (Estimate)
December 14, 2015
Last Update Submitted That Met QC Criteria
December 11, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 2013BCB022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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