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

Head Injuries, Closed Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00006128
• Other study ID #: 199/15289
• Secondary ID: BCM-H4373
• Status: Recruiting
• Phase: N/A
• First received: August 3, 2000
• Last updated: June 23, 2005
• Start date: July 1998

Study information

• Verified date: December 2003
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 374
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

• 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 Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Injuries, Closed

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario
United States	Callier Center	Dallas	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas- Houston Medical School	Houston	Texas
United States	University of California San Diego Cancer Center	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Baylor College of Medicine

Countries where clinical trial is conducted

United States,  Canada,