Study of Neurobehavioral Outcome in Children or Adolescents With Closed Head Injuries

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease
Head Injuries, Closed

Detailed Description:

PROTOCOL OUTLINE: This is a multicenter study. Patients are assigned to one of two study groups based on when the closed head injury (CHI) occurred.

Study I (CHI that occurred at least 3 years ago): Patients undergo standardized and computer based testing of cognition, attention, planning ability, organizational ability, memory, fine motor functioning, reading and math skills, language, and behavioral and emotional functioning on day 1. Patients then undergo brain magnetic resonance imaging (MRI) on the same day. While each patient undergoes testing, the patient's parent/guardian answers interview questions regarding the patient's functional and emotional status since the injury, and the family's functional status, exposure to stressful events, and psychiatric history. Prior to the visit, a questionnaire regarding classroom behaviors, such as ability to focus in school and perform class work, is mailed to each patient's teacher.

Study II (recently diagnosed CHI): Patients undergo neurobehavioral and psychological testing as in study I once during hospitalization or soon after discharge, and then at 3, 6, 12, and 24 months. Patients undergo brain MRI at 3 months. While each patient undergoes testing, the patient's parent/guardian answers interview questions as in study I. Prior to each visit, the same questionnaire as in study I is mailed to each patient's teacher.

Both studies: A brief written summary of the patient's test results may be provided to the patient, parent/guardian, school, pediatrician, or other professional at the request of the patient and parent/guardian.

Study Design

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Study Type :	Observational
Enrollment :	374 participants
Primary Purpose:	Screening
Study Start Date :	July 1998

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	up to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

• 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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, California
University of California San Diego Cancer Center	Active, not recruiting
La Jolla, California, United States, 92093-0658
United States, Texas
Callier Center	Recruiting
Dallas, Texas, United States, 75235
Contact: Sandra Chapman 214-905-3007
Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Harvey S. Levin 713-798-4860
University of Texas- Houston Medical School	Recruiting
Houston, Texas, United States, 77030
Contact: Linda Ewing-Cobbs 713-500-3888
Canada, Ontario
Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Maureen Dennis 416-813-6658

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Baylor College of Medicine

Investigators

Study Chair:	Harvey S. Levin	Baylor College of Medicine

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00006128 History of Changes
Other Study ID Numbers:	199/15289; BCM-H4373
First Posted:	August 4, 2000
Last Update Posted:	June 24, 2005
Last Verified:	December 2003

Keywords provided by National Center for Research Resources (NCRR):

neurologic and psychiatric disorders; rare disease

Additional relevant MeSH terms:

Craniocerebral Trauma; Head Injuries, Closed; Trauma, Nervous System	Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating