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

Chang WH, Park CH, Kim DY, Shin YI, Ko MH, Lee A, Jang SY, Kim YH

BMC neurology2 Mar 2016Cited by 53 (Europe PMC)

PMID26934986PMCIDPMC4776414DOI10.1186/s12883-016-0553-zPepBankPUB-26934986

Summary

BackgroundCerebrolysin 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).

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In subacute stroke patients, motor function improved in both groups without a significant difference between Cerebrolysin and placebo.
In plain wordsIn stroke patients, motor function improved in both groups, with no significant difference between Cerebrolysin and placebo.
Peptide
Cerebrolysin
Outcome
No significant changeMotor function
Study
n = 70
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
Dose not stated · 21-dayAs given in this study (human).
Measurements
p value for motor function improvement
< 0.05
motor function improvement within both groups
Source sentences
Summary
Both groups demonstrated significant improvement in motor function (p < 0.05); however, no significant difference was found between the two groups.
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-2693498601
02HumanRandomized controlled trialEfficacy outcome
In stroke patients with severe motor impairment, Cerebrolysin improved motor function more than placebo.
In plain wordsIn stroke patients with severe motor impairment, Cerebrolysin improved movement more than placebo.
Peptide
Cerebrolysin
Outcome
IncreaseMotor function in severe impairment
Study
n: not reported in source
Comparator
Placebo
Outcome group
Exercise and physical function · Nervous system and cognition
Studied dose
Dose not stated · 21-dayAs given in this study (human).
Measurements
p value for motor function improvement
< 0.05
motor function improvement, Cerebrolysin versus placebo, severe motor impairment subgroup
Source sentences
Summary
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).
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-2693498602
03HumanRandomized controlled trialMechanism
In subacute stroke patients, Cerebrolysin restricted increments of corticospinal diffusivity.
In plain wordsIn stroke patients, Cerebrolysin restricted increases in corticospinal diffusivity.
Peptide
Cerebrolysin
Outcome
Direction not reportedCorticospinal diffusivity increments
Study
n: not reported in source
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
Dose not stated · 21-dayAs given in this study (human).
Source sentences
Summary
Effects of Cerebrolysin were demonstrated as restricted increments of corticospinal diffusivity and as recovery of the sensorimotor connectivity.
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-2693498603
04HumanRandomized controlled trialMechanism
In subacute stroke patients, Cerebrolysin was associated with recovery of sensorimotor connectivity.
In plain wordsIn stroke patients, Cerebrolysin was associated with recovery of connections involved in sensation and movement.
Peptide
Cerebrolysin
Outcome
IncreaseSensorimotor connectivity recovery
Study
n: not reported in source
Outcome group
Neuroprotection · Nervous system and cognition
Studied dose
Dose not stated · 21-dayAs given in this study (human).
Source sentences
Summary
Effects of Cerebrolysin were demonstrated as restricted increments of corticospinal diffusivity and as recovery of the sensorimotor connectivity.
1 context sentence(design, population, supporting numbers)
Summary · context
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.
Show in the study text Report a problemFND-2693498604

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT01996761

Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke

Samsung Medical Centern = 71Jan 2011 to Feb 2014

Cerebrolysin

Trial page ClinicalTrials.govUpdated 11 May 2016

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
14 Oct 2026, 05:02 UTC
Study results updated
Version 1
14 Oct 2026, 01:46 UTC
First added · source update from Europe PMC

Subjects

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