Overview

Methylphenidate for Attention Problems After Pediatric TBI

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
0
Participant gender:
All
Summary
Traumatic Brain Injury (TBI) - methylphenidate treatment
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Treatments:
Methylphenidate
Criteria
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