Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006128
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-08-03
Brief Title:
Study of Neurobehavioral Outcome in Children or Adolescents With Closed Head Injuries
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 patients parentguardian answers interview questions regarding the patients functional and emotional status since the injury and the familys 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 patients 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 patients parentguardian answers interview questions as in study I Prior to each visit the same questionnaire as in study I is mailed to each patients teacher
Both studies A brief written summary of the patients test results may be provided to the patient parentguardian school pediatrician or other professional at the request of the patient and parentguardian
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 patients parentguardian answers interview questions regarding the patients functional and emotional status since the injury and the familys 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 patients 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 patients parentguardian answers interview questions as in study I Prior to each visit the same questionnaire as in study I is mailed to each patients teacher
Both studies A brief written summary of the patients test results may be provided to the patient parentguardian school pediatrician or other professional at the request of the patient and parentguardian
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCM-H4373 | None | None | None |