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Study of Neurobehavioral Outcome in Children or Adolescents With Closed Head Injuries

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00006128
First received: August 3, 2000
Last updated: June 23, 2005
Last verified: December 2003
  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: Primary Purpose: Screening

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 374
Study Start Date: July 1998
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.

  Eligibility

Ages Eligible for Study:   up to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006128

Locations
United States, California
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
United States, Texas
Callier Center
Dallas, Texas, United States, 75235
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas- Houston Medical School
Houston, Texas, United States, 77030
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
National Center for Research Resources (NCRR)
Baylor College of Medicine
Investigators
Study Chair: Harvey S. Levin Baylor College of Medicine
  More Information

ClinicalTrials.gov Identifier: NCT00006128     History of Changes
Other Study ID Numbers: 199/15289  BCM-H4373 
Study First Received: August 3, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Craniocerebral Trauma
Head Injuries, Closed
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on December 06, 2016