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

This study is currently recruiting patients.

Sponsored by: National Center for Research Resources (NCRR)
Baylor College of Medicine
Information provided by: National Center for Research Resources (NCRR)

Purpose

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
Head Injuries, Closed

MedlinePlus related topics:  Head and Brain Injuries

Study Type: Observational
Study Design: Screening

Further Study Details: 

Expected Total Enrollment:  374

Study start: July 1998

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.

Eligibility

Ages Eligible for Study:  up to  12 Years,  Genders Eligible for Study:  Both

Criteria


Location and Contact Information


California
      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States; Recruiting
Jeffrey Max  858-576-5832 

Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
Harvey S. Levin  713-798-4860 

      Callier Center, Dallas,  Texas,  75235,  United States; Recruiting
Sandra Chapman  214-905-3007 

      University of Texas- Houston Medical School, Houston,  Texas,  77030,  United States; Recruiting
Linda Ewing-Cobbs  713-500-3888 

Canada, Ontario
      Hospital for Sick Children, Toronto,  Ontario,  M5G 1X8,  Canada; Recruiting
Maureen Dennis  416-813-6658 

Study chairs or principal investigators

Harvey S. Levin,  Study Chair,  Baylor College of Medicine   

More Information

Study ID Numbers:  199/15289; BCM-H4373
Record last reviewed:  December 2003
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006128
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-18
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