Subacute methylphenidate treatment for moderate to moderately severe traumatic brain injury: a preliminary double-blind placebo-controlled study.

OBJECTIVE: To determine the effect of subacute administration of methylphenidate on recovery from moderate to moderately severe closed head injury.
DESIGN: Double-blind placebo-controlled with random assignment. Patients were enrolled when their Galveston Orientation and Amnesia Test score was at least 65. Drug/placebo treatment began the day following baseline cognitive assessment and continued for 30 consecutive days. Follow-up evaluations were conducted at 30 and 90 days after baseline, after discontinuation of drug/placebo.
SETTING: A level I trauma center. PATIENTS: Twenty-three patients ranging in age from 16 to 64 years. Head injury severity ranged from moderately severe (Glasgow Coma Score [GCS] < or = 8, no intracranial pressure monitor) to "complicated mild" (GCS from 13 to 15 with positive computed tomography brain scan). Thirty-day follow-up was based on 12 patients, whereas 90-day evaluation was based on 9 patients, with complicated mild head injuries excluded from the analyses.
INTERVENTIONS: Methylphenidate administered twice daily at a dose of .30 mg/kg; placebo administered according to the same schedule in identical pill form. MAIN OUTCOME MEASURES: The Disability Rating Scale (DRS) and tests of attention, memory, and vigilance.
RESULTS: The methylphenidate group was significantly better at 30 days on the DRS (p < .02), and on tests of attention (p < .03) and motor performance (p, .05). No significant differences were noted between groups at 90 days.
CONCLUSIONS: Subacute administration of methylphenidate after moderately severe head injury appeared to enhance the rate but not the ultimate level of recovery as measured by the DRS and tests of vigilance. Problems with possible selection bias and small sample size limit generalization of results.

RCT Entities:   Population Interventions Outcomes