title: The Specific Requirements of Neural Repair Trials for Stroke.
abstract: Novel molecular, cellular, and pharmacological therapies to stimulate repair of sensorimotor circuits after stroke are entering clinical trials. Compared with acute neuroprotection and thrombolysis studies, clinical trials for repair in subacute and chronic hemiplegic participants have a different time course for delivery of an intervention, different mechanisms of action within the milieu of the injury, distinct relationships to the amount of physical activity and skills practice of participants, and need to include more refined outcome measures. This review examines the biological interaction of targeted rehabilitation with neural repair strategies to optimize outcomes. We suggest practical guidelines for the incorporation of inexpensive skills training and exercise at home. In addition, we describe some novel outcome measurement tools, including wearable sensors, to obtain the more detailed outcomes that may identify at least some minimal level of success from cellular and regeneration interventions. Thus, proceeding in the shadow of acute stroke trial designs may unnecessarily limit the mechanisms of action of new repair strategies, reduce their impact on participants, and risk missing important behavioral outcomes.
authors.affiliation: David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
authors.forename: Bruce H
authors.initials: BH
authors.lastname: Dobkin
authors.affiliation: David Geffen School of Medicine at UCLA, Los Angeles, CA, USA scarmichael@mednet.ucla.edu.
authors.forename: S Thomas
authors.initials: ST
authors.lastname: Carmichael
mesh_terms: D000818:Animals; D001921:Brain / Q000502:physiology*; D006801:Humans; D020127:Recovery of Function / Q000502:physiology*; D020521:Stroke / Q000473:pathology* / Q000503:physiopathology*; D000071939:Stroke Rehabilitation
keywords: axonal sprouting; clinical trials; mHealth; brain tissue regeneration; neuronal plasticity; physical therapy; stem cell; stroke rehabilitation