Methylphenidate for Attention Problems After Pediatric TBI

The objectives of the study are to (1) determine the efficacy and dose-response of
methylphenidate treatment of attention problems after pediatric traumatic brain injury (TBI)
and (2) provide a better understanding of the relationship of a prior history of attention
deficit hyperactivity disorder (ADHD), ADHD subtypes after TBI, executive function, and
attentional control to treatment efficacy. The proposed clinical trial will enroll 50
children, age 6-17 years, with attention problems >6 months after moderate to severe TBI
into a randomized, double-blind, placebo-controlled, cross-over design trial with 3 dose
conditions (low, medium, and high).

Inclusion Criteria:

- Between ages of 6-17

- Sustained Moderate to Severe TBI

- TBI occurred at least 6 months prior to beginning the study

- TBI occurred no earlier than 5 years of age

- Positive endorsement of 6 out of 9 items on the Vanderbilt ADHD inattention or
hyperactivity scale

Exclusion Criteria:

- History of developmental disability or mental retardation

- Current active participation in ADHD-related behavioral intervention

- History of psychiatric condition requiring an inpatient admission in past 12 months

- Actively taking medications with a contraindication to Concerta that cannot be
discontinued

- Current use of stimulant medication or ADHD specific medications that cannot be
discontinued

- Non-blunt head injury

- Family history of arrhythmia

- Pregnancy