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

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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

Tracking Information
First Submitted Date October 25, 2014
First Posted Date October 28, 2014
Last Update Posted Date December 14, 2015
Study Start Date March 2014
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 27, 2014)
MRI and cognitive function scale [ Time Frame: up to 5 years after first assessment ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MRI,Gene And Cognitive Performance Study of Patients With Cerebral White Matter Lesions(WMLs)
Official Title MRI,Gene And Cognitive Performance Study of Patients With Cerebral White Matter Lesions
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
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA extracted from whole blood sample
Sampling Method Non-Probability Sample
Study Population patients with cerebral white matter lesions
Condition Cerebral White Matter Lesions
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 27, 2014)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2019
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02276976
Other Study ID Numbers 2013BCB022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wei Wang, Huazhong University of Science and Technology
Study Sponsor Wei Wang
Collaborators Not Provided
Investigators
Principal Investigator: Wei Wang, Doctor Tongji Hospital
PRS Account Huazhong University of Science and Technology
Verification Date December 2015