NCT00283647

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

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2002

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

3.9 years

First QC Date

January 27, 2006

Last Update Submit

April 13, 2015

Conditions

Keywords

lead exposuremagnetic resonance imagingmagnetic resonance spectroscopyfunctional magnetic resonancebrain development

Eligibility Criteria

Age19 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

Study Officials

  • Kim M Cecil, PhD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

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

Locations