Cerebrolysin Combined with Rehabilitation Enhances Motor Recovery and Prevents Neural Network Degeneration in Ischemic Stroke Patients with Severe Motor Deficits
Abstract
:1. Introduction
2. Materials and Methods
2.1. Experimental Design
2.2. Randomization and Blinding
2.3. Functional Assessments
2.4. Imaging Assessments
2.4.1. Diffusion Tensor Imaging Data Analysis
2.4.2. Resting State Functional Magnetic Resonance Imaging Data Analysis
2.5. Statistical Analysis
3. Results
3.1. Participants
3.2. Motor Function Outcomes
3.3. Results of Functional Imaging Data Analysis
3.4. Safety Analysis
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Parameters | Cerebrolysin (n = 59) | Placebo (n = 51) | p-Value |
---|---|---|---|
Sex (male:female) | 34:25 | 32:19 | 0.585 |
Age (mean ± SD, years) | 68.6 ± 10.8 | 66.1 ± 12.8 | 0.246 |
Stroke side (Rt:Lt) | 21:38 | 26:25 | 0.104 |
Baseline stroke severity (mean ± SD) | |||
NIHSS | 9.0 ± 3.9 | 9.0 ± 4.0 | 0.882 |
MMSE | 19.6 ± 9.0 | 18.7 ± 10.1 | 0.618 |
FMA-T | 26.2 ± 13.6 | 21.6 ± 13.7 | 0.085 |
FMA-UL | 12.8 ± 9.9 | 10.6 ± 8.4 | 0.220 |
FMA-LL | 13.4 ± 7.4 | 11.0 ± 7.4 | 0.097 |
Lesion volume (cm3) | 43.9 ± 66.7 | 69.9 ± 90.5 | 0.117 |
MEP response (n (%)) | 13 (22.0%) | 10 (19.6%) | 0.817 |
Parameter | T0–T1 | T1–T2 | T0–T2 | |
---|---|---|---|---|
ΔFMA-T | Cerebrolysin | 11.0 ± 11.8 | 12.3 ± 13.4 * | 23.3 ± 15.9 |
Placebo | 13.8 ± 15.2 | 6.7 ± 10.5 | 20.5 ± 18.8 | |
ΔFMA-UL | Cerebrolysin | 7.6 ± 8.7 | 8.2 ± 9.3 * | 15.8 ± 12.6 |
Placebo | 8.2 ± 11.0 | 4.4 ± 8.1 | 12.5 ± 13.3 | |
ΔFMA-LL | Cerebrolysin | 3.3 ± 5.0 | 4.0 ± 6.0 | 7.4 ± 6.3 |
Placebo | 5.6 ± 6.0 | 2.4 ± 4.8 | 8.0 ± 7.2 |
Cerebrolysin Group | Placebo Group | p-Value | |||||
---|---|---|---|---|---|---|---|
T0 | T2 | p-Value | T0 | T2 | p-Value | ||
Diffusion tensor imaging | |||||||
Corticospinal tract | 0.901 ± 0.070 | 0.816 ± 0.095 | <0.001 * | 0.885 ± 0.084 | 0.757 ± 0.113 | <0.001 * | 0.0167 † |
Superior corona radiata | 0.887 ± 0.103 | 0.833 ± 0.145 | <0.001 * | 0.859 ± 0.115 | 0.747 ± 0.175 | <0.001 * | 0.0185 † |
Superior longitudinal fasciculus | 0.917 ± 0.145 | 0.861 ± 0.199 | <0.001 * | 0.908 ± 0.127 | 0.800 ± 0.225 | <0.001 * | 0.0305 † |
Whole hemispheric tracts | 0.935 ± 0.063 | 0.897 ± 0.082 | <0.001 * | 0.925 ± 0.064 | 0.856 ± 0.110 | <0.001 * | 0.0263 † |
Genu of corpus callosum | 0.480 ± 0.046 | 0.465 ± 0.050 | <0.001 * | 0.485 ± 0.039 | 0.455 ± 0.056 | <0.001 * | 0.0091 † |
Body of corpus callosum | 0.516 ± 0.054 | 0.494 ± 0.056 | <0.001 * | 0.523 ± 0.042 | 0.486 ± 0.062 | <0.001 * | 0.0256 † |
Splenium of corpus callosum | 0.629 ± 0.059 | 0.612 ± 0.061 | <0.001 * | 0.638 ± 0.044 | 0.611 ± 0.058 | <0.001 * | 0.0449 † |
Resting-state functional imaging | |||||||
Ipsilesional connectivity | 0.222 ± 0.088 | 0.217 ± 0.079 | 0.6735 | 0.238 ± 0.065 | 0.191 ± 0.078 | 0.0014 * | 0.0280 † |
Contralesional connectivity | 0.295 ± 0.084 | 0.270 ± 0.074 | 0.0741 | 0.292 ± 0.059 | 0.281 ± 0.086 | 0.4588 | 0.4866 |
Interhemispheric connectivity | 0.436 ± 0.151 | 0.448 ± 0.137 | 0.5095 | 0.403 ± 0.151 | 0.415 ± 0.151 | 0.5825 | 0.9731 |
Network efficiency | 0.313 ± 0.057 | 0.302 ± 0.060 | 0.2386 | 0.314 ± 0.044 | 0.294 ± 0.058 | 0.0270 * | 0.4600 |
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Chang, W.H.; Lee, J.; Shin, Y.-I.; Ko, M.-H.; Kim, D.Y.; Sohn, M.K.; Kim, J.; Kim, Y.-H. Cerebrolysin Combined with Rehabilitation Enhances Motor Recovery and Prevents Neural Network Degeneration in Ischemic Stroke Patients with Severe Motor Deficits. J. Pers. Med. 2021, 11, 545. https://doi.org/10.3390/jpm11060545
Chang WH, Lee J, Shin Y-I, Ko M-H, Kim DY, Sohn MK, Kim J, Kim Y-H. Cerebrolysin Combined with Rehabilitation Enhances Motor Recovery and Prevents Neural Network Degeneration in Ischemic Stroke Patients with Severe Motor Deficits. Journal of Personalized Medicine. 2021; 11(6):545. https://doi.org/10.3390/jpm11060545
Chicago/Turabian StyleChang, Won Hyuk, Jungsoo Lee, Yong-Il Shin, Myoung-Hwan Ko, Deog Young Kim, Min Kyun Sohn, Jinuk Kim, and Yun-Hee Kim. 2021. "Cerebrolysin Combined with Rehabilitation Enhances Motor Recovery and Prevents Neural Network Degeneration in Ischemic Stroke Patients with Severe Motor Deficits" Journal of Personalized Medicine 11, no. 6: 545. https://doi.org/10.3390/jpm11060545