- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00880451
Development and Decline of Brain and Cognition Through the Life Span
March 15, 2021 updated by: National Institute of Mental Health (NIMH)
The protocol objectives are to enable prospective IRB review of research using human MRI scans and data collected under other branch protocols or extramural sources.
By combining data from multiple sources the investigators will be able to conduct analyses that require large numbers of observations that exceed the numbers collected in any single study.
They will also be able to stratify and subgroup the combined samples in different ways to permit analyses that would otherwise not be possible.
The study population consists of normal individuals and clinical groups of all ages.
Clinical groups will be added by amendment including patients suffering from schizophrenia, ADHD, autism, Klinefelter's disease, and Alzheimer's disease.
The study design consists of 1) automated segmentation of MRI brain scans to obtain regional measurements of cortical thickness and volumetric measurements of brain structures including basal ganglia, 2) manual segmentation of brain structures and brain anomalies not amenable to automated segmentation such as Virchow-Robbins spaces, 3) correlation analyses between MRI brain measurements and available demographic (e.g.
gender) and physiological (e.g.
BMI) data, statistical analysis of group differences where the groups are defined by diagnosis, age, gender or by other potentially useful classification.
Since all data were collected under other protocols there are no additional risks or benefits associated with this protocol.
This protocol combines MRI data from disparate sources and can provide important information regarding factors that may affect the comparability of MRI scans obtained from different sites using various types of MRI scanners and pulse sequences to generate MRI images.
It will also enable the analysis of specific subgroups with sufficient numbers of observations for meaningful statistics.
Study Overview
Status
Completed
Conditions
Detailed Description
The protocol objectives are to enable prospective IRB review of research using human MRI scans and data collected under other branch protocols or extramural sources.
By combining data from multiple sources, the investigators will be able to conduct analyses that require large numbers of observations that exceed the numbers collected in any single study.
They will also be able to stratify and subgroup the combined samples in different ways to permit analyses that would otherwise not be possible.
The study population consists of normal individuals and clinical groups of all ages.
Clinical groups will be added by amendment, including patients suffering from schizophrenia, ADHD, autism, Klinefelter's disease, and Alzheimer's disease.
The study design consists of 1) automated segmentation of MRI brain scans to obtain regional measurements of cortical thickness and volumetric measurements of brain structures including basal ganglia, 2) manual segmentation of brain structures and brain anomalies not amenable to automated segmentation such as Virchow-Robbins spaces, 3) correlation analyses between MRI brain measurements and available demographic (e.g.
gender) and physiological (e.g.
BMI) data, statistical analysis of group differences where the groups are defined by diagnosis, age, gender or by other potentially useful classification.
Since all data were collected under other protocols there are no additional risks or benefits associated with this protocol.
This protocol combines MRI data from disparate sources and can provide important information regarding factors that may affect the comparability of MRI scans obtained from different sites using various types of MRI scanners and pulse sequences to generate MRI images.
It will also enable the analysis of specific subgroups with sufficient numbers of observations for meaningful statistics.
Study Type
Observational
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
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institute of Mental Health (NIMH), 9000 Rockville Pike
-
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- Data Analysis Only
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Francois M Lalonde, Ph.D., National Institute of Mental Health (NIMH)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
March 1, 2009
Study Registration Dates
First Submitted
April 10, 2009
First Submitted That Met QC Criteria
April 10, 2009
First Posted (Estimate)
April 13, 2009
Study Record Updates
Last Update Posted (Actual)
March 16, 2021
Last Update Submitted That Met QC Criteria
March 15, 2021
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999909027
- 09-M-N027
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.
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