The case for modality-specific outcome measures in clinical trials of stroke recovery-promoting agents.
Clinical trials for acute stroke treatments have often used composite clinical rating scales as primary outcome measures of treatment efficacy. Recent preclinical and clinical studies highlight the opportunity to administer treatments in the subacute and chronic phase of stroke to promote neurological recovery. Because different neurological deficits recover to different extents at different rates after stroke, putative stroke recovery-promoting treatments may exert differential effects on various functional aspects of stroke recovery. For this reason, we propose that the use of modality-specific outcome measures may be best suited as primary end points in clinical trials of stroke recovery-promoting agents. The use of such end points may result in a more selective labeling of stroke recovery treatments.
Cramer
Steven C
SC
Department of Neurology, University of California, Irvine, CA, USA.
Koroshetz
Walter J
WJ
Finklestein
Seth P
SP
D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D004185:Disability Evaluation; D006801:Humans; D018696:Neuroprotective Agents / Q000627:therapeutic use; D017063:Outcome Assessment, Health Care / Q000379:methods*; D018579:Patient Selection; D011788:Quality of Life; D020127:Recovery of Function / Q000502:physiology*; D015983:Selection Bias; D020521:Stroke / Q000503:physiopathology / Q000628:therapy*; D015912:Thrombolytic Therapy / Q000379:methods / Q000592:standards
D018696:Neuroprotective Agents