title: Cerebrolysin combined with rehabilitation promotes motor recovery in patients with severe motor impairment after stroke.
abstract: 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT01996761 (November 5, 2013).
authors.affiliation: Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-gu, Seoul, 135-710, Korea. wh.chang@samsung.com.
authors.forename: Won Hyuk
authors.initials: WH
authors.lastname: Chang
authors.affiliation: Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-gu, Seoul, 135-710, Korea. park.changhyun@hanmail.net.
authors.forename: Chang-hyun
authors.initials: CH
authors.lastname: Park
authors.affiliation: Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Korea. kimdy@yuhs.ac.
authors.forename: Deog Young
authors.initials: DY
authors.lastname: Kim
authors.affiliation: Department of Rehabilitation Medicine, Pusan National University School of Medicine, Pusan National University Yangsan Hospital, Pusan, Korea. rmshin@pusan.ac.kr.
authors.forename: Yong-Il
authors.initials: YI
authors.lastname: Shin
authors.affiliation: Department of Physical Medicine and Rehabilitation, Research Institute of Clinical Medicine of Chonbuk National University, Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Korea. mhko@chonbuk.ac.kr.
authors.forename: Myoung-Hwan
authors.initials: MH
authors.lastname: Ko
authors.affiliation: Department of Health Science and Technology, Department of Medical Device Management & Research, SAIHST, Sungkyunkwan University, Seoul, Korea. ahee.lee@gmail.com.
authors.forename: Ahee
authors.initials: A
authors.lastname: Lee
authors.affiliation: HVS Imaging Center, Heart Vascular Stroke Institute, Samsung Medical Center, Seoul, Korea. bautai.jang@partner.samsung.com.
authors.forename: Shin Yi
authors.initials: SY
authors.lastname: Jang
authors.affiliation: Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, Gangnam-gu, Seoul, 135-710, Korea. yunkim@skku.edu.|Department of Health Science and Technology, Department of Medical Device Management & Research, SAIHST, Sungkyunkwan University, Seoul, Korea. yunkim@skku.edu.
authors.forename: Yun-Hee
authors.initials: YH
authors.lastname: Kim
mesh_terms: D000368:Aged; D000596:Amino Acids / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020521:Stroke / Q000188:drug therapy*; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome
chemical_list: D000596:Amino Acids; C006952:cerebrolysin