Does Lead Burden Alter Neuropsychological Development?



Sponsors


Source

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

Completed

Start Date

N/A

Completion Date

N/A

Primary Completion Date

N/A

Study Type

Observational


Condition


Intervention

Intervention Type

Procedure

Intervention Name



Eligibility

Criteria

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

Gender

Female

Minimum Age

N/A

Maximum Age

N/A

Healthy Volunteers

Accepts Healthy Volunteers


Location

Facility

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

Location Countries

Country

United States


Verification Date

2003-12-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Keyword


Has Expanded Access

No

Condition Browse


Secondary Id

M01RR000400

Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Defined Population

Time Perspective

Longitudinal


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


ClinicalTrials.gov processed this data on August 24, 2018

Conditions

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

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.



© 2018 ICH GCP