Published Online
on March 1, 2007

A more recent version of this article appeared on April 1, 2007

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Submitted on August 22, 2006
Revised on October 29, 2006
Accepted on October 30, 2006

The Case for Modality-Specific Outcome Measures in Clinical Trials of Stroke Recovery-Promoting Agents

Steven C. Cramer MD; Walter J. Koroshetz MD; and Seth P. Finklestein MD^*

From Departments of Neurology and Anatomy & Neurobiology (S.C.C.), University of California, Irvine, Calif; Department of Neurology (W.J.K.), Massachusetts General Hospital and Harvard Medical School, Boston, Mass; Biotrofix, Inc (S.P.F.), Needham, Mass.

^* To whom correspondence should be addressed. E-mail: seth.finklestein{at}biotrofix.com.

Abstract--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.

Key words: clinical trials • outcome measures • stroke recovery

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