Trial Information

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.