To characterize the benefits and optimal dose of long-acting methylphenidate for management of long-term attention problems after childhood traumatic brain injury (TBI).
Phase 2, randomized, double-masked, placebo-controlled, dose-titration, crossover clinical trial.
Outpatient, clinical research.
Twenty-six children aged 6 to 17 years who were at least 6 months post-TBI and met criteria for attention-deficit hyperactivity disorder (ADHD) at the time of enrollment.
Vanderbilt Rating Scale of attention problems, Pittsburgh Side Effects Rating Scale, and vital signs.
Among the 26 participants randomized, 20 completed the trial. The mean ages at injury and enrollment were 6.3 and 11.5 years, respectively. Eight participants had a severe TBI. On an optimal dose of medication, greater reductions were found on the Vanderbilt Parent Rating Scale for the medicated condition than for placebo (P = .022, effect size = 0.59). The mean optimal dose of methylphenidate was 40.5 mg (1.00 mg/kg/day). Preinjury ADHD diagnosis status was not associated with a differential medication response. Methylphenidate was associated with weight loss (∼1 kg), increased systolic blood pressure (∼3- to 6-point increase), and mild reported changes in appetite.
Findings support use of long-acting methylphenidate for management of long-term attention problems after pediatric TBI. Larger trials are warranted of stimulant medications, including comparative effectiveness and combination medication and nonmedication interventions.
Division of Physical Medicine and Rehabilitation (Drs Kurowski, Pruitt, and Wade), Division of Behavioral Medicine and Clinical Psychology (Dr Epstein), Division of Neurology (Dr Horn), and Division of Biostatistics and Epidemiology (Dr Altaye), Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; and Departments of Pediatrics and Neurology and Rehabilitation Medicine (Drs Kurowski and Pruitt) and Department of Pediatrics (Drs Epstein, Horn, Altaye, and Wade), University of Cincinnati College of Medicine, Cincinnati, Ohio.
Corresponding Author: Brad G. Kurowski, MD, MS, Division of Physical Medicine and Rehabilitation, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH 45229 (Brad.Kurowski@cchmc.org).
This project was supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development grant K23HD074683 and, in part, by the Cincinnati Children's Research Foundation, and the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1 TR001425 and the National Institute on Disability, Independent Living, and Rehabilitation Research, formerly known as the National Institute on Disability and Rehabilitation Research (grant number 90RT5004).
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or other supporting agencies.
The authors declare no conflicts of interest.
Trial Registration: NCT01933217