No benefit from D-amphetamine when added to physiotherapy after stroke: a randomized, placebo-controlled study

Objective: To assess the effect of D-amphetamine on the recovery of activities of daily living and motor functions after stroke, Design: Randomized, placebo-controlled study, Setting: Inpatient rehabilitation centre, Subjects: Twenty-four stroke survivors after a first ischaemic supratentorial stroke within six weeks before study onset, severely to moderately affected, with a Barthel Index (0–100) ranging from 25 to 50, no severe concomitant internal, neurological or psychiatric diseases, and participating in a comprehensive rehabilitation programme of 10–12 weeks, Interventions: Ten sessions with 10 mg D-amphetamine (or placebo) every fourth day totalling 100 mg in a time period of 36 days combined with physical therapy according to the neurodevelopmental concept within 60 minutes after drug intake. Main outcome measures: Barthel Index (0–100) served as the primary outcome measure and the Rivermead Motor Assessment Score with its three sections (gross function, leg and trunk, and arm) as the secondary outcome measure, assessed at days 0, 20, 36, 90, 180 and 360. Results: The two groups did not differ with respect to clinical data and outcome measures at study onset. All patients improved significantly except for arm function over the intervention period and up to day 90 after study onset. The comparison between groups did not reveal any difference at any time; amphetamine-treated patients did not show any increase in motor function or ADL compared with the control group. Conclusions: The placebo-controlled study failed to show any effect of D-amphetamine on stroke recovery compared with control. The small number of patients, the timing and content of physical therapy were limiting factors of the present study. Further trials are warranted.