Study of Neurobehavioral Outcome in Children or Adolescents With Closed Head Injuries
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| ClinicalTrials.gov Identifier: NCT00006128 |
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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
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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.
| Condition or disease |
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| Head Injuries, Closed |
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 Type : | Observational |
| Enrollment : | 374 participants |
| Primary Purpose: | Screening |
| Study Start Date : | July 1998 |
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| Ages Eligible for Study: | up to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006128
| 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 | |
| Study Chair: | Harvey S. Levin | Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00006128 History of Changes |
| Other Study ID Numbers: |
199/15289 BCM-H4373 |
| First Posted: | August 4, 2000 Key Record Dates |
| Last Update Posted: | June 24, 2005 |
| Last Verified: | December 2003 |
Keywords provided by National Center for Research Resources (NCRR):
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neurologic and psychiatric disorders rare disease |
Additional relevant MeSH terms:
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Craniocerebral Trauma Head Injuries, Closed Trauma, Nervous System |
Nervous System Diseases Wounds and Injuries Wounds, Nonpenetrating |