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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02761148
Other study ID # Z14H180003
Secondary ID
Status Recruiting
Phase N/A
First received May 2, 2016
Last updated June 10, 2017
Start date January 2014
Est. completion date December 2019

Study information

Verified date June 2017
Source Zhejiang University
Contact Minming Zhang, Ph.D
Phone 13906520711
Email zhangminming@zju.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 85 Years
Eligibility Inclusion criteria:

1. white matter hyperintensity visible on T2 fluid-attenuated inversion recovery images;

2. age between 35 to 80 years;

3. without stroke lesion (except lacunar infarction) on current diffusion weighted images;

4. without a history of multiple sclerosis, Alzheimer's disease, Parkinson's disease and head trauma.

Exclusion criteria:

1. white matter lesions of nonvascular origin (immunological-demyelinating, metabolic, toxic, infectious, other);

2. intracranial hemorrhage;

3. with severe head motion on magnetic resonance images

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China The 2nd Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fazekas Scale of white matter hyperintensity 1 year
Primary Mini-Mental State Examination (MMSE) 1 year
Primary Hamilton Depression Scale (HAMD) 1 year
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