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Home > "S" Clinical Trials Conditions > Study of Neurobehavioral Outcome in Children or Adolescents With Closed Head Injuries  Study of Neurobehavioral Outcome in Children or Adolescents With Closed Head Injuries
Study of Neurobehavioral Outcome in Children or Adolescents With Closed Head Injuries
For Condition: Head Injuries, Closed
Status: Recruiting
Sponsor(s): National Center for Research Resources (NCRR) , Baylor College of Medicine
Synopsis: 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.
Details: 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:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /12 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 374
Location and Contact Information:
Overall Study Official:
HarveyLevin, Study Chair, Baylor College of Medicine
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Harvey Levin 713-798-4860
University of Texas- Houston Medical School *Recruiting*
Houston, Texas, 77030
United States
Recruiting Linda Ewing-Cobbs 713-500-3888
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Maureen Dennis 416-813-6658
Callier Center *Recruiting*
Dallas, Texas, 75235
United States
Recruiting Sandra Chapman 214-905-3007
University of California San Diego Cancer Center *Recruiting*
La Jolla, California, 92093-0658
United States
Recruiting Jeffrey Max 858-576-5832
Additional Information:
Study ID Numbers: 199/15289; BCM-H4373
Study Start Date: July 1998
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006128
Other Head Injuries, Closed Studies:
1. Study of Neurobehavioral Outcome in Children or Adolescents With Closed Head Injuries
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Study of Neurobehavioral Outcome in Children or Adolescents With Closed Head Injuries
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