Clinical trial NCT01933217: Methylphenidate for Attention Problems After Pediatric TBI
Official title: Efficacy of Methylphenidate for Management of Long-Term Attention Problems After Pediatric Traumatic Brain Injury (TBI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Traumatic Brain Injury
TBI
ADHD
Keywords: TBI
traumatic brain injury
ADHD
methylphenidate
Concerta
attention problems
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2013-09-02
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Traumatic Brain Injury (TBI) - methylphenidate treatment

Detailed description: 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).

Eligibility 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

Primary outcomes:
measure: Parent Outcome-Vanderbilt ADHD Parent Rating Scales (VADPRS)
timeFrame: Reported at End of Methylphenidate Arm (Week 4 or 8)
measure: Parent Outcome-Behavior Rating Inventory of Executive Functioning (BRIEF)
timeFrame: Reported at End of Methylphenidate Arm (Week 4 or 8)
Secondary outcomes:
measure: Neuropsychological Outcome- Wechsler Intelligence Scale for Children, 4th Edition Processing Speed Index (WISC-IV-PSI)
timeFrame: Reported at End of Methylphenidate Arm (Week 4 or 8)
measure: Teacher Outcome Measure
timeFrame: January 1, 2014 - July 20, 2017
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Brad Kurowski, MS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kurowski BG, Epstein JN, Pruitt DW, Horn PS, Altaye M, Wade SL. Benefits of Methylphenidate for Long-Term Attention Problems After Traumatic Brain Injury in Childhood: A Randomized, Double-Masked, Placebo-Controlled, Dose-Titration, Crossover Trial. J Head Trauma Rehabil. 2019 Mar/Apr;34(2):E1-E12. doi: 10.1097/HTR.0000000000000432.