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| Sponsor: | National Center for Research Resources (NCRR) |
|---|---|
| Collaborator: |
Baylor College of Medicine |
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00006128 |
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 |
| Study Type: | Observational |
| Study Design: | Screening |
| Estimated Enrollment: | 374 |
| Study Start Date: | 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 |
| Accepts Healthy Volunteers: | No |
Contacts and Locations| United States, California | |
| University of California San Diego Cancer Center | Active, not recruiting |
| La Jolla, California, United States, 92093-0658 | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Harvey S. Levin 713-798-4860 | |
| Callier Center | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Sandra Chapman 214-905-3007 | |
| 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 |
More Information
| Study ID Numbers: | 199/15289, BCM-H4373 |
| Study First Received: | August 3, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006128 History of Changes |
| Health Authority: | United States: Federal Government |
|
neurologic and psychiatric disorders rare disease |
|
Craniocerebral Trauma Nervous System Diseases Wounds and Injuries Disorders of Environmental Origin |
Head Injuries, Closed Wounds, Nonpenetrating Trauma, Nervous System |