- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02761148
The Relationship Between White Matter Hyperintensity With Cognition and Emotion
June 10, 2017 updated by: Minming Zhang, Zhejiang University
White matter hyperintensity (WMH) has been found to be related with cognitive and emotional dysfunction.
A presumed mechanism is that WMH disrupts the structural connectivity within a large-scale brain network, thereby impairing the brain's ability to integrate the neural processes efficiently.
It is not yet clear, what the pattern of brain network disruption relates to WMH and how the brain network disruption induced by WMH has an effect on cognition and emotion performance.
Using multi-model magnetic resonance imaging (MRI) techniques, we aimed to explore the mechanisms of cognitive decline and depression related with brain network dysfunction in patients with WMH, and to provide objective imaging marker for early diagnosis and prevention of WMH associated cognitive decline and depression.
Study Overview
Status
Unknown
Conditions
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 Locations
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Recruiting
- The 2nd Affiliated Hospital of Zhejiang University, School of Medicine,
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Contact:
- Xinfeng Yu, PhD
- Phone Number: 86-18758187391
- Email: angek-4125@163.com
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Principal Investigator:
- Minming Zhang, PhD
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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
31 years to 81 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
aged patients with white matter hyperintensity
Description
Inclusion criteria:
- white matter hyperintensity visible on T2 fluid-attenuated inversion recovery images;
- age between 35 to 80 years;
- without stroke lesion (except lacunar infarction) on current diffusion weighted images;
- without a history of multiple sclerosis, Alzheimer's disease, Parkinson's disease and head trauma.
Exclusion criteria:
- white matter lesions of nonvascular origin (immunological-demyelinating, metabolic, toxic, infectious, other);
- intracranial hemorrhage;
- with severe head motion on magnetic resonance images
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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Control
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White matter hyperintensity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Fazekas Scale of white matter hyperintensity
Time Frame: 1 year
|
1 year
|
|
Mini-Mental State Examination (MMSE)
Time Frame: 1 year
|
1 year
|
|
Hamilton Depression Scale (HAMD)
Time Frame: 1 year
|
1 year
|
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
January 1, 2014
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
May 2, 2016
First Submitted That Met QC Criteria
May 2, 2016
First Posted (Estimate)
May 4, 2016
Study Record Updates
Last Update Posted (Actual)
June 14, 2017
Last Update Submitted That Met QC Criteria
June 10, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z14H180003
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.