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

Further Study Details: 

Expected Total Enrollment:  374

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.

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

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

California
      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States; No longer recruiting
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
      Callier Center, Dallas,  Texas,  75235,  United States; Recruiting
      University of Texas- Houston Medical School, Houston,  Texas,  77030,  United States; Recruiting
Canada, Ontario
      Hospital for Sick Children, Toronto,  Ontario,  M5G 1X8,  Canada; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  199/15289; BCM-H4373
Record last reviewed:  December 2003
Last Updated:  March 23, 2005
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006128
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08