Does Lead Burden Alter Neuropsychological Development?



National Center for Research Resources (NCRR)

Brief Summary

Inner city children are at an increased risk for lead overburden. This in turn affects
cognitive functioning. However, the underlying neuropsychological effects of lead overburden
and its age-specific effects have not been well delineated. This study is part of a larger
study on the effects of lead overburden on the development of attention and memory. The
larger study is using a multi-model approach to study the effects of lead overburden on these
effects including the event-related potential (ERP), electrophysiologic measures of attention
and memory are studied. Every eight months, for a total of three sessions the subjects will
complete ERP measures of attention and memory which require them to watch various computer
images while wearing scalp electrodes recording from 11 sites. It is this test that we are
going to be doing on CRC. There will be 30 lead overburdened children recruited from the
larger study for participation in the ERP studies on CRC. These 30 children will be matched
with 30 children without lead overburden. This portion of the study is important in providing
an index of physiological functioning to be used along with behaviorally based measures of
attention and memory, and for providing information about the different measures.

Overall Status


Start Date


Completion Date


Primary Completion Date


Study Type




Intervention Type


Intervention Name



Inclusion Criteria:

- Pregnant mothers of the Phillips neighborhood in Minneapolis, Minnesota. Subject
recruitment will take place in local clinics which serve pregnant women and offspring



Minimum Age


Maximum Age


Healthy Volunteers

Accepts Healthy Volunteers



Department of Neurology 420 Delaware St. SE, Box 486 Mayo
Minneapolis Minnesota 55455 United States

Location Countries


United States

Verification Date


Lastchanged Date


Firstreceived Date



Has Expanded Access


Condition Browse

Secondary Id


Firstreceived Results Date


Firstreceived Results Disposition Date


Study Design Info

Observational Model

Defined Population

Time Perspective


Study First Submitted

November 3, 1999

Study First Submitted Qc

November 3, 1999

Study First Posted

November 4, 1999

Last Update Submitted

June 23, 2005

Last Update Submitted Qc

June 23, 2005

Last Update Posted

June 24, 2005 processed this data on August 24, 2018


Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.

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