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

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ClinicalTrials.gov Identifier: NCT00006128
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
First Posted : August 4, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by:
National Center for Research Resources (NCRR)

August 3, 2000
August 4, 2000
June 24, 2005
July 1998
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No Changes Posted
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Study of Neurobehavioral Outcome in Children or Adolescents With Closed Head Injuries
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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.

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.

Observational
Primary Purpose: Screening
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Head Injuries, Closed
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
374
Same as current
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  • 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
Sexes Eligible for Study: All
up to 12 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00006128
199/15289
BCM-H4373
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National Center for Research Resources (NCRR)
Baylor College of Medicine
Study Chair: Harvey S. Levin Baylor College of Medicine
National Center for Research Resources (NCRR)
December 2003