AgedNCT02761148
The Relationship Between White Matter Hyperintensity With Cognition and Emotion
An observational study of Aged and Leukoaraiosis, run by Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged, Leukoaraiosis
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: aged patients with white matter hyperintensity
Who may be able to join
- 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.
Who cannot join
- white matter lesions of nonvascular origin (immunological-demyelinating, metabolic, toxic, infectious, other);
- intracranial hemorrhage;
- with severe head motion on magnetic resonance images
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 2nd Affiliated Hospital of Zhejiang University, School of Medicine,
Hangzhou, Zhejiang, 310009
Xinfeng Yu, PhD, 86-18758187391, angek-4125@163.com
Minming Zhang, PhD
About this study
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.
- Conditions
- Aged, Leukoaraiosis
- Keywords
- white matter hyperintensity, brain network, MRI, cognition, emotion
- Medical subject headings
- Leukoaraiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described | |
| White matter hyperintensity | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fazekas Scale of white matter hyperintensity
Measured: 1 year
Mini-Mental State Examination (MMSE)
Measured: 1 year
Hamilton Depression Scale (HAMD)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Minming Zhang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761148
- Sponsor's protocol ID
- Z14H180003
- Status last verified
- Jun 2017
- First submitted
- 2 May 2016
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between White Matter Hyperintensity With Cognition and Emotion
- ClinicalTrials.gov ID
- NCT02761148
- Acronym / sponsor ID
- Z14H180003
- Conditions
- Aged, Leukoaraiosis
- Keywords
- white matter hyperintensity, brain network, MRI, cognition, emotion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | – |
| White matter hyperintensity | – | – |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- aged patients with white matter hyperintensity
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- white matter lesions of nonvascular origin (immunological-demyelinating, metabolic, toxic, infectious, other);
- intracranial hemorrhage;
- with severe head motion on magnetic resonance images
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fazekas Scale of white matter hyperintensity
Time frame: 1 year
Mini-Mental State Examination (MMSE)
Time frame: 1 year
Hamilton Depression Scale (HAMD)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aged and Leukoaraiosis, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minming Zhang, Ph.D (13906520711, zhangminming@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fazekas Scale of white matter hyperintensity (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.