Cerebral White Matter LesionsNCT02276976
MRI,Gene And Cognitive Performance Study of Patients With Cerebral White Matter Lesions(WMLs)
An observational study of Cerebral White Matter Lesions, run by Wei Wang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral White Matter Lesions
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Sep 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with cerebral white matter lesions
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Wei Wang, Doctor, 86-027-8366-3648, tianyalinghu@126.com
Wei Wang, Doctor
About this study
Official title: MRI,Gene And Cognitive Performance Study of Patients With Cerebral White Matter Lesions
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
Read the detailed description
100 patients with cerebral white matter lesions and 100 normal controls will be observed. All of them will receive MRI scan(T1WI,T2WI,T2flair,MRA,SWI,ASL,DTI and fMRI) and the assessment of the neuropsychological function (MMSE,Auditory verbal memory test,Trail-making test-A and -B,Symbol digit modalities test,Digit span test,Clock drawing test,HAMD) intending to analyse 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.Furthermore,DNA will be extracted from the blood sample of all participates to perform High-throughput sequencing. MRI scan and neuropsychological function assessment will be performed repeatedly after 1,3 and 5 years.
- Conditions
- Cerebral White Matter Lesions
- Keywords
- crebral white matter lesions, brain networks, MRI, DTI, fMRI, cognitive impairment, gene
- Medical subject headings
- Cognitive Dysfunction
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 |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI and cognitive function scale
Measured: up to 5 years after first assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2016 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral White Matter LesionsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Wang, Huazhong University of Science and Technology
- Investigators
- Wei Wang, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276976
- Sponsor's protocol ID
- 2013BCB022
- Status last verified
- Dec 2015
- First submitted
- 25 Oct 2014
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI,Gene And Cognitive Performance Study of Patients With Cerebral White Matter Lesions
- ClinicalTrials.gov ID
- NCT02276976
- Acronym / sponsor ID
- 2013BCB022
- Conditions
- Cerebral White Matter Lesions
- Keywords
- crebral white matter lesions, brain networks, MRI, DTI, fMRI, cognitive impairment, gene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Wei WangUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 28 Oct 2014 (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.
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
Detailed description
100 patients with cerebral white matter lesions and 100 normal controls will be observed. All of them will receive MRI scan(T1WI,T2WI,T2flair,MRA,SWI,ASL,DTI and fMRI) and the assessment of the neuropsychological function (MMSE,Auditory verbal memory test,Trail-making test-A and -B,Symbol digit modalities test,Digit span test,Clock drawing test,HAMD) intending to analyse 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.Furthermore,DNA will be extracted from the blood sample of all participates to perform High-throughput sequencing. MRI scan and neuropsychological function assessment will be performed repeatedly after 1,3 and 5 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with cerebral white matter lesions
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
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
MRI and cognitive function scale
Time frame: up to 5 years after first assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
Related trials for Cerebral White Matter Lesions
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Not yet recruitingObservational study
MRI-Based Neurodevelopmental Risk Stratification in Infants With White Matter Injury
Punctate White Matter Lesions, Neurodevelopmental Outcomes
RecruitingPhase 2
UCSD Image-Guided Cognitive-Sparing Radiosurgery for Intracranial Lesions
Brain Metastases, Adult, Neurocognitive Function
RecruitingObservational study
MRI-Based Lesion Differentiation in Older Patients With Multiple Sclerosis
Multiple Sclerosis (MS), Cerebral Small Vessel Diseases
Not yet recruiting
Quantitative 3D UltraSound Brain Imaging: Development of New Bedside Biomarkers to Better Predict Neurodevelopmental Outcomes in Preterm Infants
Very Preterm Infants Born < 30 Weeks of Gestation
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.
Wei Wang, Doctor principal investigator
Tongji Hospital
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 Cerebral White Matter Lesions, run by Wei Wang 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 1 inclusion and 1 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 Dec 2015. 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 Wei Wang, Doctor (86-027-8366-3648, tianyalinghu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI and cognitive function scale (time frame: up to 5 years after first assessment). 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 Dec 2015.