NCT02276976

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

1.9 years

First QC Date

October 25, 2014

Last Update Submit

December 11, 2015

Conditions

Keywords

crebral white matter lesionsbrain networksMRIDTIfMRIcognitive impairmentgene

Outcome Measures

Primary Outcomes (1)

  • MRI and cognitive function scale

    up to 5 years after first assessment

Study Arms (2)

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

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with cerebral white matter lesions

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA extracted from whole blood sample

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Wei Wang, Doctor

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

October 25, 2014

First Posted

October 28, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2016

Study Completion

September 1, 2019

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations