Biomarker-based patient selection improves stroke rehabilitation trial efficiency

BioRxiv : the Preprint Server for Biology
Cathy M StinearSteve Cramer

Abstract

Background and Purpose: Inter-subject variability complicates trials of novel stroke rehabilitation therapies, particularly in the sub-acute phase after stroke. We tested whether selecting patients using motor evoked potential (MEP) status, a physiological biomarker of motor system function, could improve trial efficiency. Methods: A retrospective analysis of data from 207 patients (103 women, mean (SD) 70.6 (15.1) years) was used to estimate sample sizes and recruitment rates required to detect a 7-point difference between hypothetical control and treatment groups in upper-limb Fugl-Meyer and Action Research Arm Test scores at 90 days post-stroke. Analyses were carried out for the full sample and for subsets defined by motor evoked potential (MEP) status. Results: Selecting patients according to MEP status reduced the required sample size by 75% compared to an unselected sample. The estimated time needed to recruit the required sample was also reduced by 72% for patients with MEPs, and was increased by 2-3-fold for patients without MEPs. Conclusions: Using biomarkers to select patients can improve stroke rehabilitation trial efficiency by reducing the sample size and recruitment time needed to detect a clinically meaningful ef...Continue Reading

Related Concepts

Biological Markers
Clinical Trials
Rehabilitation Therapy
Retrospective Studies
Cerebrovascular Accident
Woman
Evoked Potentials, Motor
Size
Analysis
Upper Extremity

Related Feeds

BioRxiv & MedRxiv Preprints

BioRxiv and MedRxiv are the preprint servers for biology and health sciences respectively, operated by Cold Spring Harbor Laboratory. Here are the latest preprint articles (which are not peer-reviewed) from BioRxiv and MedRxiv.