Abstract
The objective of this study was to evaluate whether Cerebrolysin combined with rehabilitation therapy supports additional motor recovery in stroke patients with severe motor impairment. This study analyzed the combined data from the two phase IV prospective, multicenter, randomized, double-blind, placebo-controlled trials. Stroke patients were included within seven days after stroke onset and were randomized to receive a 21-day treatment course of either Cerebrolysin or placebo with standardized rehabilitation therapy. Assessments were performed at baseline, immediately after the treatment course, and 90 days after stroke onset. The plasticity of the motor system was assessed by diffusion tensor imaging and resting state fMRI. In total, 110 stroke patients were included for the full analysis set (Cerebrolysin n = 59, placebo n = 51). Both groups showed significant motor recovery over time. Repeated-measures analysis of varianceshowed a significant interaction between time and type of intervention as measured by the Fugl–Meyer Assessment (p < 0.05). The Cerebrolysin group demonstrated less degenerative changes in the major motor-related white matter tracts over time than the placebo group. In conclusion, Cerebrolysin treatment as an add-on to a rehabilitation program is a promising pharmacologic approach that is worth considering in order to enhance motor recovery in ischemic stroke patients with severe motor impairment.
Highlights
Stroke is a leading cause of adult disability in Korea as well as worldwide [1]
Neuroplasticity is the basic principle for the recovery of motor function after stroke, and strategies to increase neuroplasticity are the gold standard for post-stroke rehabilitation [5]
Inclusion and exclusion criteria for the second trial (NCT02768571) were the same as those used in the first trial (NCT02768571) [15], with the exception of motor impairment score measured by a total score of FMA (FMA-T) at the 7th day after stroke onset, which ranged from 0 to 49 [17]
Summary
Stroke is a leading cause of adult disability in Korea as well as worldwide [1]. Stroke mortality rates in Korea have shown substantial declines, the number of patients suffering from residual stroke disability is increasing [2]. Management, and rehabilitative treatment have had a significant impact on clinical and functional outcomes after stroke [3]. Even though these advances have had clinical benefits, many stroke survivors still suffer from significant motor impairments [4]. Neuroplasticity is the basic principle for the recovery of motor function after stroke, and strategies to increase neuroplasticity are the gold standard for post-stroke rehabilitation [5]. The subacute stroke stage, characterized by higher neuroplasticity, is a critical period for therapy as, during this stage, the brain is most receptive to modification by rehabilitative experiences [6,7]
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