NCT02761148

Brief 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.

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 Jan 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

January 1, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

5.9 years

First QC Date

May 2, 2016

Last Update Submit

June 10, 2017

Conditions

Keywords

white matter hyperintensitybrain networkMRIcognitionemotion

Outcome Measures

Primary Outcomes (3)

  • Fazekas Scale of white matter hyperintensity

    1 year

  • Mini-Mental State Examination (MMSE)

    1 year

  • Hamilton Depression Scale (HAMD)

    1 year

Study Arms (2)

Control

White matter hyperintensity

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

aged patients with white matter hyperintensity

You may qualify if:

  • 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.

You may not qualify if:

  • white matter lesions of nonvascular origin (immunological-demyelinating, metabolic, toxic, infectious, other);
  • intracranial hemorrhage;
  • with severe head motion on magnetic resonance images

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 2nd Affiliated Hospital of Zhejiang University, School of Medicine,

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Leukoaraiosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Minming Zhang, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief,Department of Radiology,The 2nd Affiliated Hospital of Zhejiang University, School of Medicine

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 4, 2016

Study Start

January 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

June 14, 2017

Record last verified: 2017-06

Locations