NCT00880451

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
Last Updated

March 16, 2021

Status Verified

September 1, 2012

First QC Date

April 10, 2009

Last Update Submit

March 15, 2021

Conditions

Keywords

Children and AdolescentsAgingBrain ImagingMRI (Magnetic Resonance Imaging)MRIMagnetic Resonance Imaging

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* Data Analysis Only

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Francois M Lalonde, Ph.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 13, 2009

Study Start

March 1, 2009

Last Updated

March 16, 2021

Record last verified: 2012-09

Locations