MR Assessment of Brain Function Altered by Lead Exposure
1 other identifier
observational
150
1 country
1
Brief Summary
Exposure to lead during pregnancy, infancy, and childhood increases the individual likelihood of impaired school performance, increased impulsiveness, aggression, and delinquent behavior. Disorders that result from exposure to environmental neurotoxicants are a complex web of interactions between genetic, neurochemical, biochemical, environmental and social factors that influence children during critical periods of development. To date, research in the area of human developmental neurotoxicology focuses primarily on global measures of sensory-motor development and cognition. However, studies elucidating the biological basis for developmental and behavioral disorders due to environmental toxicant exposure are lacking. Although gross brain structure appears normal, underlying problems exist at a neural level. Our proposal seeks to relate childhood environmental lead exposure at various levels and stages of development with detriments in brain structure and neurochemical functioning assessed with magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). Cortical and subcortical brain volumes will be determined with high resolution MRI. Neuronal and glial cell markers will be measured using proton MRS. These structural and chemical measures will also be correlated with behavioral measures from the young adult participants of the Cincinnati Lead Study (CLS). These participants represent a unique and ideal cohort of approximately 240 subjects with detailed histories of exposure and behavioral outcomes in lead exposed children monitored for approximately 20 years. A pilot study examining language, working memory and attention in combination with functional magnetic resonance imaging (fMRI) will also be performed to better understand the functional and behavioral deficits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2002
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
January 27, 2006
CompletedFirst Posted
Study publicly available on registry
January 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedApril 14, 2015
April 1, 2015
3.9 years
January 27, 2006
April 13, 2015
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Participant in the Cincinnati Lead Study.
- Age range of at least 18 years with an upper limit of 25 years.
- Negative history for metabolic, neurologic, cardiac disease.
- Negative family history for metabolic or neurologic disease (in first-degree relatives only) to include genetic disorders.
You may not qualify if:
- Presence of an implant such as a hearing aid, cochlear implant, pacemaker or neuro-stimulator containing electrical circuitry or generating electrical signals or having moving metal parts.
- Presence of metal implants, orthopedic pins or plates above the level of the waist.
- Presence of orthodontic braces.
- Subjects who demonstrate or express noticeable anxiety and/or cannot readily communicate with personnel operating the MR equipment will be excluded.
- Pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center, Dept. of Radiology and the Imaging Research Center
Cincinnati, Ohio, 45229, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Kim M Cecil, PhD
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
January 27, 2006
First Posted
January 30, 2006
Study Start
October 1, 2002
Primary Completion
September 1, 2006
Study Completion
September 1, 2006
Last Updated
April 14, 2015
Record last verified: 2015-04