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Assessment of Attentional Functioning in Children With HIV-1 Infection

Primary Purpose

Attention Deficit Disorder With Hyperactivity, HIV Infections, Paralysis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Attention Deficit Disorder With Hyperactivity focused on measuring Brain Imaging, Encephalopathy, Hyperactivity, Neuroimmunology, Reaction Time Tasks

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Children and adolescents with HIV infection ages 5-18. Have to be on another treatment protocol at the Division of Clinical Sciences, NCI. No children with non-HIV associated CNS compromise, such as for example resulting from head trauma, or genetic factors. No children with uncorrectable (20/20) vision.

Sites / Locations

  • National Cancer Institute (NCI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001497
Brief Title
Assessment of Attentional Functioning in Children With HIV-1 Infection
Official Title
Assessment of Attentional Functioning in Children With HIV-1 Infection
Study Type
Observational

2. Study Status

Record Verification Date
November 1999
Overall Recruitment Status
Completed
Study Start Date
December 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Children with symptomatic HIV-1 (Human Immunodeficiency Virus) infection are at increased risk for developing severely disabling neurological and neuropsychological deficits. HIV-1 related CNS (Central Nervous System) disease is a clinical syndrome, manifested by varying and sometimes discordant degrees of cognitive, motor and behavioral impairment. A continuum of clinical presentations attributed to the effects of HIV-1 infection on the CNS, ranging from apparently normal development, decreases in the rate of new learning to the loss of acquired skills have been observed. Two domains of psychological functioning appear most susceptible to the effects of HIV infection on the central nervous system in children: expressive behavior and attentional processes (Brouwers, et al, 1994). Attention deficits have been documented as a relative weakness on the "freedom from distractibility" subclass of IQ tests (Brouwers et al, 1989) and on behavior assessment (Moss et al, 1994). Attention, however, has many subcomponents such as focused attention, divided attention, vigilance, etc. Direct assessment of attentional functioning using reaction time has not yet been conducted and questions whether attentional components are differentially affected by the virus have not been addressed. The proposed study would assess different components of attentional functioning in children with HIV-1 disease. A quantitative and systematic method is developed that could complement the existing standardized instruments used for measuring attention and neurocognitive function in this population. Simple alerted visual reaction time will be measured with varying preparatory intervals, a two-choice reaction time in a go/no-go paradigm will be administered, and a continuous performance, divided reaction time test and an object decision task will be given. Performance on these measures will also be related to measures of brain structure and stage of HIV-1 disease.
Detailed Description
Children with symptomatic HIV-1 (Human Immunodeficiency Virus) infection are at increased risk for developing severely disabling neurological and neuropsychological deficits. HIV-1 related CNS (Central Nervous System) disease is a clinical syndrome, manifested by varying and sometimes discordant degrees of cognitive, motor and behavioral impairment. A continuum of clinical presentations attributed to the effects of HIV-1 infection on the CNS, ranging from apparently normal development, decreases in the rate of new learning to the loss of acquired skills have been observed. Two domains of psychological functioning appear most susceptible to the effects of HIV infection on the central nervous system in children: expressive behavior and attentional processes (Brouwers, et al, 1994). Attention deficits have been documented as a relative weakness on the "freedom from distractibility" subclass of IQ tests (Brouwers et al, 1989) and on behavior assessment (Moss et al, 1994). Attention, however, has many subcomponents such as focused attention, divided attention, vigilance, etc. Direct assessment of attentional functioning using reaction time has not yet been conducted and questions whether attentional components are differentially affected by the virus have not been addressed. The proposed study would assess different components of attentional functioning in children with HIV-1 disease. A quantitative and systematic method is developed that could complement the existing standardized instruments used for measuring attention and neurocognitive function in this population. Simple alerted visual reaction time will be measured with varying preparatory intervals, a two-choice reaction time in a go/no-go paradigm will be administered, and a continuous performance, divided reaction time test and an object decision task will be given. Performance on these measures will also be related to measures of brain structure and stage of HIV-1 disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, HIV Infections, Paralysis
Keywords
Brain Imaging, Encephalopathy, Hyperactivity, Neuroimmunology, Reaction Time Tasks

7. Study Design

Enrollment
90 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Children and adolescents with HIV infection ages 5-18. Have to be on another treatment protocol at the Division of Clinical Sciences, NCI. No children with non-HIV associated CNS compromise, such as for example resulting from head trauma, or genetic factors. No children with uncorrectable (20/20) vision.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
6590573
Citation
Brouwers P, Riccardi R, Poplack D, Fedio P. Attentional deficits in long-term survivors of childhood acute lymphoblastic leukemia (ALL). J Clin Neuropsychol. 1984 Aug;6(3):325-36. doi: 10.1080/01688638408401222.
Results Reference
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PubMed Identifier
7826274
Citation
Brouwers P, DeCarli C, Civitello L, Moss H, Wolters P, Pizzo P. Correlation between computed tomographic brain scan abnormalities and neuropsychological function in children with symptomatic human immunodeficiency virus disease. Arch Neurol. 1995 Jan;52(1):39-44. doi: 10.1001/archneur.1995.00540250043011.
Results Reference
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PubMed Identifier
8338344
Citation
DeCarli C, Civitello LA, Brouwers P, Pizzo PA. The prevalence of computed tomographic abnormalities of the cerebrum in 100 consecutive children symptomatic with the human immune deficiency virus. Ann Neurol. 1993 Aug;34(2):198-205. doi: 10.1002/ana.410340216.
Results Reference
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Assessment of Attentional Functioning in Children With HIV-1 Infection

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