NCT00006128

Brief Summary

OBJECTIVES: I. Determine the relationship of closed head injury (CHI) severity, focal brain lesions, and the age at injury to the development of working memory, inhibition, and metacognitive skills in children or adolescents with CHI of varying severity. II. Assess the development of working memory, inhibition, and metacognitive skills in relation to discourse functions, scholastic achievement, and adaptive behavior in these patients. III. Determine the relationship between impaired inhibition, metacognitive skills, and the emergence of psychiatric disorder in these patients.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
374

participants targeted

Target at P75+ for all trials

Geographic Reach
2 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

August 3, 2000

Last Update Submit

June 23, 2005

Conditions

Head Injuries, Closed

Keywords

neurologic and psychiatric disordersrare disease

Eligibility Criteria

Age0 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
* Study I: Closed head injury (CHI) that occurred at least 3 years ago * Study II: Recently diagnosed CHI * Both studies: Eligible if CHI resulted from acceleration, deceleration, or impact by a blunt object (e.g., motor vehicle accidents, pedestrian-vehicular injury, falls, assault except child abuse by caregiver) Preinjury emotional/behavioral problems allowed except mental retardation, autism, schizophrenia, or pervasive developmental disorder that would confound evaluation of cognitive function

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (5)

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

ACTIVE NOT RECRUITING

Callier Center

Dallas, Texas, 75235, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

University of Texas- Houston Medical School

Houston, Texas, 77030, United States

RECRUITING

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

MeSH Terms

Conditions

Head Injuries, ClosedNeurologic ManifestationsMental DisordersRare Diseases

Condition Hierarchy (Ancestors)

Craniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, NonpenetratingSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Harvey S. Levin

    Baylor College of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 3, 2000

First Posted

August 4, 2000

Study Start

July 1, 1998

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations

CA(1)US(4)