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Original Investigation
December 2018

Effect of Dextroamphetamine on Poststroke Motor Recovery: A Randomized Clinical Trial

Author Affiliations
  • 1Department of Neurology, Kentucky Neuroscience Institute, University of Kentucky, Lexington
  • 2Department of Neurology, Columbia University, New York, New York
  • 3Department of Neurology, Department of Veterans Affairs Medical Center 127, Oklahoma City, Oklahoma
  • 4Department of Neurology, Penn State University, Hershey, Pennsylvania
  • 5Department of Neurology, Burke Rehabilitation Hospital, Yonkers, New York
  • 6MedStar National Rehabilitation Hospital, Washington, DC
  • 7Department of Rehabilitation Medicine, Georgetown University, Washington, DC
  • 8Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina
JAMA Neurol. 2018;75(12):1494-1501. doi:10.1001/jamaneurol.2018.2338
Key Points

Question  Does the administration of dextroamphetamine combined with physiotherapy improve poststroke motor recovery?

Findings  In this pilot randomized clinical trial of 64 patients with ischemic stroke, no overall treatment-associated difference in the change in Fugl-Meyer motor scores from baseline to 3 months after treatment, no overall treatment-associated differences in any of the study’s secondary measures, and no differences in any subgroup based on stroke location or baseline severity were found. No adverse events were attributed to study treatments.

Meaning  This study found no evidence that dextroamphetamine combined with physiotherapy improves poststroke motor recovery.

Abstract

Importance  Data from animal models show that the administration of dextroamphetamine combined with task-relevant training facilitates recovery after focal brain injury. Results of clinical trials in patients with stroke have been inconsistent.

Objectives  To collect data important for future studies evaluating the effect of dextroamphetamine combined with physiotherapy for improving poststroke motor recovery and to test the efficacy of the approach.

Design, Setting, Participants  This pilot, double-blind, block-randomized clinical trial included patients with cortical or subcortical ischemic stroke and moderate or severe motor deficits from 5 rehabilitation hospitals or units. Participants were screened and enrolled from March 2001 through March 2003. The primary outcome was assessed 3 months after stroke. Study analysis was completed December 31, 2015. A total of 1665 potential participants were screened and 64 were randomized. Participants had to begin treatment 10 to 30 days after ischemic stroke. Data analysis was based on intention to treat.

Interventions  Participants were allocated to a regimen of 10 mg of dextroamphetamine (n = 32) or placebo (n = 32) combined with a 1-hour physical therapy session beginning 1 hour after drug or placebo administration every 4 days for 6 sessions in addition to standard rehabilitation.

Main Outcomes and Measures  The primary outcome was the difference between groups in change in Fugl-Meyer motor scores from baseline to 3 months after stroke (intention to treat with dextroamphetamine). Secondary exploratory measures included the National Institutes of Health Stroke Scale, Canadian Neurological Scale, Action Research Arm Test, modified Rankin Scale score, Functional Independence Measure, Ambulation Speed and Distance, Mini-Mental State Examination, Beck Depression Inventory, and Stroke Impact Scale.

Results  Among the 64 patients randomized to dextroamphetamine vs placebo (55% men; median age, 66 years; age range, 27-91 years), no overall treatment-associated difference in the mean (SEM) change in Fugl-Meyer motor scores from baseline to 3 months after stroke was noted (−18.65 [2.27] points with dextroamphetamine vs −20.83 [2.94] points with placebo; P = .58). No overall treatment-associated differences in any of the study’s secondary measures and no differences in subgroups based on stroke location or baseline severity were found. No adverse events were attributed to study treatments.

Conclusions and Relevance  Treatment with dextroamphetamine combined with physical therapy did not improve recovery of motor function compared with placebo combined with physical therapy as assessed 3 months after hemispheric ischemic stroke. The studied treatment regimen was safe.

Trial Registration  ClinicalTrials.gov identifier: NCT01905371

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