http://bmcneurol.biomedcentral.com/articles/10.1186/s12883-016-0553-z
- Won Hyuk Chang†,
- Chang-hyun Park†,
- Deog Young Kim,
- Yong-Il Shin,
- Myoung-Hwan Ko,
- Ahee Lee,
- Shin Yi Jang and
- Yun-Hee KimEmail author
†Contributed equally
BMC NeurologyBMC series – open, inclusive and trusted201616:31
DOI: 10.1186/s12883-016-0553-z
© Chang et al. 2016
Received: 23 June 2015
Accepted: 25 February 2016
Published: 2 March 2016
Abstracts
Background
Cerebrolysin 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.
Methods
This 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.
Results
Both 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.
Conclusion
The 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 registration
NCT01996761 (November 5, 2013)
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