Dextroamphetamine Plus Physical Therapy Nonsuperior to Placebo for Improving Post-Stroke Motor Recovery
No significant difference was observed between the treatment and placebo arms in change in the Fugl-Meyer motor scores from baseline to 3-month follow-up.
Physical therapy plus dextroamphetamine, an amphetamine enantiomer and stimulant of the central nervous system, is not associated with 3-month improvements in motor function recovery compared with placebo plus physical therapy in patients with hemispheric ischemic stroke, according to study findings published in JAMA Neurology.
Patients with cortical or subcortical ischemic stroke and moderate or severe motor deficits were enrolled in the study. Researchers randomly assigned participants to receive either 10 mg dextroamphetamine (n=32) or placebo (n=32). Both interventions were combined with a 1-hour physical therapy session 1 hour after administration of the treatment drug or placebo. Therapy sessions occurred every 4 days for a total of 6 sessions.
At 3 months post-stroke, the investigators compared the 2 groups with regard to the change in Fugl-Meyer motor scores from baseline. Additional secondary measures included changes in the Action Research Arm Test, Ambulation Speed and Distance, Beck Depression Inventory, Canadian Neurological Scale, Functional Independence Measure, National Institutes of Health Stroke Scale, modified Rankin Scale score, Mini-Mental State Examination, and Stroke Impact Scale.
No significant difference was observed between the treatment and placebo arms with regard to the change in the Fugl-Meyer motor scores from baseline to 3-month follow-up (−18.65 [2.27] vs −20.83 [2.94] points, respectively; P =.58). The investigators observed no differences between dextroamphetamine or placebo for any of the secondary measures, including National Institutes of Health Stroke Scale (overall mean [SEM] difference, −4.84 [0.75] vs −4.96 [0.77] points, respectively; P =.97) and Canadian Neurological Score (mean [SEM] difference, 1.95 [0.27] vs 2.04 [0.33] points, respectively; P =.66).
In addition, there were no significant differences in terms of the Functional Independence Measure (mean [SEM] difference, 38.29 [3.31] vs 34.46 [2.84] points; P =.46), Ambulation Distance (mean [SEM] difference, 109.64 [21.36] vs 67.71 [19.55] m; P =.16), Ambulation Speed (mean [SEM] difference, 9.41 [7.69] vs 9.49 [2.85] m/min; P =.21), Research Action Arm Test (mean [SEM] difference, 7.24 [2.72] vs 12.83 [3.69] points; P =.08), Mini-Mental State Examination (mean [SEM] difference, 4.90 [2.23] vs 17.58 [3.49] points; P =.12), and Beck Depression Inventory (mean [SEM] difference, −3.03 [1.16] vs −1.43 [1.66] points; P =.15) by 3 months. There were no serious treatment-related adverse events.
Limitations of the study include the small number of patients, the lack of an active comparator group, and the inclusion of only 1 dosing strategy for the study drug.
“Future studies could assess other strategies for modulating central neurotransmitters and other subgroups of participants,” the researchers wrote.
Goldstein LB, Lennihan L, Rabadi MJ, et al. Effect of dextroamphetamine on poststroke motor recovery: a randomized clinical trial [published online August 27, 2018]. JAMA Neurol. doi:10.1001/jamaneurol.2018.2338