Traumatic Brain Injury | Methylphenidate for Attention Problems After Pediatric TBI
Traumatic Brain Injury research study
What is the primary objective of this study?
Traumatic Brain Injury (TBI) - methylphenidate treatment
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Traumatic Brain Injury
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
MethylphenidateThe study medication will consist of identical capsules filled Concerta® over-encapsulated to preserve double-blinding. The weekly dosages will be low, medium, and high based on weight cut-offs. Participants weighing less than 25kg will receive 18mg (low), 27mg (medium), and 36mg (high) dosages and participants weighing above 25kg will receive 18mg (low), 36mg (medium), and 54mg (high) dosages during the 3-week upward titration trial. Weekly ratings monitoring behavioral and side effect symptoms score and the Pittsburgh Side Effects Rating Scale.
PlaceboThe study medication will consist of identical capsules filled with an inert white power (placebo). Weekly ratings monitoring behavioral and side effect symptoms score and the Pittsburgh Side Effects Rating Scale.
Start Date: November 2013
Completed Date: August 2018
Phase: Phase 4
Primary Outcome: Parent report measures
Secondary Outcome: Neuropsychological Testing
Study sponsors, principal investigator, and references
Principal Investigator: Brad Kurowski, MS, MD
Lead Sponsor: Children's Hospital Medical Center, Cincinnati