Cerebrolysin combined with rehabilitation promotes motor recovery in patients with severe motor impairment after stroke

Abstract

AbstractsBackgroundCerebrolysin is a neuropeptide preparation with neuroprotective and neurorestorative effects. Combining Cerebrolysin treatment with a standardized rehabilitation program may have a potential synergistic effect in the subacute stage of stroke. This study aims to evaluate whether Cerebrolysin provides additional motor recovery on top of rehabilitation therapy in the subacute stroke patients with moderate to severe motor impairment.MethodsThis phase IV trial was designed as a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. A total of 70 patients (Cerebrolysin n = 35, placebo n = 35) with moderate to severe motor function impairment were included within 7 days after stroke onset and were randomized to receive a 21-day treatment course of either Cerebrolysin or placebo, given in addition to standardized rehabilitation therapy. Assessments were performed at baseline, immediately after treatment as well as 2 and 3 months after stroke onset. The plasticity of motor system was assessed by diffusion tensor imaging and with resting state functional magnetic resonance imaging.ResultsBoth groups demonstrated significant improvement in motor function (p < 0.05); however, no significant difference was found between the two groups. In the stroke patients with severe motor impairment, the Cerebrolysin group exhibited significantly more improvement in motor function compared with the placebo group (p < 0.05). Effects of Cerebrolysin were demonstrated as restricted increments of corticospinal diffusivity and as recovery of the sensorimotor connectivity.ConclusionThe combination of standard rehabilitation therapy with Cerebrolysin treatment in the subacute stroke has shown additional benefit on motor recovery and plastic changes of the corticospinal tract in patients with severe motor impairment.Trial registrationNCT01996761 (November 5, 2013)

Safety and efficacy of recovery-promoting drugs for motor function after stroke: A systematic review of randomized controlled trials

“…Four studies compared 2 drug intervention arms with placebo (28)(29)(30)(31). Four studies evaluated MLC 601 (NeuroAid ™ ) and involved the largest proportion of participants (n = 2,099, 37.2%) (32)(33)(34)(35)(36). The most frequently studied pharmacological interventions were disability when taking risk of harm into account (7).…”

Cerebrolysin for functional recovery in patients with acute ischemic stroke: a meta-analysis of randomized controlled trials

“…Ultimately, we identified six RCTs for meta-analysis 13–18. All of the included RCTs were international multicenter trials except for two studies 16,17. The detailed characteristics of the included studies are listed in Table 1.…”

“…The unexpected mildly affected patients in these studies might be the main cause of the inconclusive results. In the subgroup of AIS patients with severe neurological deficits at baseline, cerebrolysin treatment showed a superiority compared with the effect of placebo in three RCTs 14,17,18. We could not perform a subgroup analysis to detect the influence of stroke severity based on the NIHSS scores at baseline due to the insufficient data from the included studies.…”

“…These confusing outcomes might be due to limitations in sample size, the selection of the included patients, and the therapeutic regimen. Three RCTs indicated a superiority of cerebrolysin compared with placebo in a subgroup of AIS patients with severe neurological deficits at baseline 14,17,18. Two recent RCTs applied several specific neurological outcome scales to examine the effect of cerebrolysin on motor functional recovery and observed inconsistent outcomes 17,18.…”

Rehabilitation in acute stroke from the point of view of evidence-based medicine: possibilities of drug treatment

“…Оценивалось влияние препарата (30 мл, 21 день терапии), назначенного в 1-ю неделю инсульта, на восстановление двигательных функций руки в дополнение к стандартной реабилитации у пациентов с умеренными и выраженными нарушениями. Преимущества назначения церебролизина были отмечены на 60-й и 90-й день в группе пациентов с выраженными двигательными нарушениями и сопровождались позитивными изменениями моторных нейрональных сетей по результатам диффузионно-тензорной и функциональной магнитно-резонансной томографии [40]. Таким образом, церебролизин представляется оптимальным препаратом для потенцирования ранней нейрореабилитации при инсульте.…”