- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006128
Study of Neurobehavioral Outcome in Children or Adolescents With Closed Head Injuries
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.
Study Overview
Status
Conditions
Detailed Description
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
Enrollment
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Recruiting
- Hospital For Sick Children
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Contact:
- Maureen Dennis
- Phone Number: 416-813-6658
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California
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La Jolla, California, United States, 92093-0658
- Active, not recruiting
- University of California San Diego Cancer Center
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Texas
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Dallas, Texas, United States, 75235
- Recruiting
- Callier Center
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Contact:
- Sandra Chapman
- Phone Number: 214-905-3007
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Houston, Texas, United States, 77030
- Recruiting
- Baylor College of Medicine
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Contact:
- Harvey S. Levin
- Phone Number: 713-798-4860
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Houston, Texas, United States, 77030
- Recruiting
- University of Texas- Houston Medical School
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Contact:
- Linda Ewing-Cobbs
- Phone Number: 713-500-3888
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- 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
Study Plan
How is the study designed?
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Harvey S. Levin, Baylor College of Medicine
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/15289
- BCM-H4373
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head Injuries, Closed
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The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR)UnknownWounds and Injuries | Closed Head InjuryCanada
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U.S. Army Medical Research and Development CommandNational Institutes of Health Clinical Center (CC); National Institute on Alcohol... and other collaboratorsCompletedTraumatic Brain Injury | Penetrating Head Injury | Closed Head TraumaUnited States
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POLYSAN Scientific & Technological Pharmaceutical...RecruitingHead Trauma,ClosedRussian Federation
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Bayside HealthCompletedDepression | Closed Head InjuryAustralia
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Centre Hospitalier Universitaire de NīmesNot yet recruitingPenetrating Head Injury | Closed Head InjuryFrance
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University of SheffieldNational Institute for Health Research, United KingdomCompletedCraniocerebral Trauma | Head Injuries, Closed
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CareFlightNSW Motor Accident AuthorityTerminated
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BrainScope Company, Inc.RecruitingTBI (Traumatic Brain Injury) | Concussion, Brain | MTBI - Mild Traumatic Brain Injury | Closed Head InjuryUnited States
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Duke UniversityCompletedHead Injuries, Closed | Head Trauma | Head Injuries | Craniocerebral Injuries | Crushing Skull Injury | Head Injuries, Multiple | Head Trauma,Closed | Head Trauma Injury | Head Trauma, Penetrating | Head Injury, Minor | Head Injury Major | Head Injury, Open | Injuries, Craniocerebral | Injuries, Head | Multiple Head... and other conditionsUnited States
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Duke UniversityCompletedHead Injuries, Closed | Head Trauma | Head Injuries | Craniocerebral Injuries | Crushing Skull Injury | Head Injuries, Multiple | Head Trauma,Closed | Head Trauma Injury | Head Trauma, Penetrating | Head Injury, Minor | Head Injury Major | Head Injury, Open | Injuries, Craniocerebral | Injuries, Head | Multiple Head... and other conditionsUnited States, Uganda