Livia Livint Popa1,2, Mihaela Iancu3, Gheorghe Livint4, Maria Balea1,2, Constantin Dina5, Vitalie Vacaras1,2, Cristian Vladescu6, Laura Balanescu6,7, Anca Dana Buzoianu8, Stefan Strilciuc9,10, Dafin Muresanu1,2. 1. Department of Neuroscience, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania. 2. RoNeuro Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania. 3. Department of Medical Informatics and Biostatistics, "Iuliu Haţieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania. 4. Department of Energy Utilisation, Electrical Drives and Industrial Automation (EUEDIA), "Gheorghe Asachi" Technical University, Iasi, Romania. 5. Faculty of Medicine, "Ovidius University", Constanta, Romania. 6. "Grigore Alexandrescu" Emergency Hospital for Children, Bucharest, Romania. 7. "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania. 8. Department of Clinical Pharmacology, "Iuliu Haţieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania. 9. Department of Neuroscience, "Iuliu Hatieganu" University of Medicine and Pharmacy, Cluj-Napoca, Romania. stefan.strilciuc@ssnn.ro. 10. RoNeuro Institute for Neurological Research and Diagnostic, Cluj-Napoca, Romania. stefan.strilciuc@ssnn.ro.
Abstract
BACKGROUND: N-Pep-12 is a dietary supplement with neuroprotective and pro-cognitive effects, as shown in experimental models and clinical studies on patients after ischemic stroke. We tested the hypothesis that N-Pep-12 influences quantitative electroencephalography (QEEG) parameters in patients with subacute to chronic supratentorial ischemic lesions. METHODS: We performed secondary data analysis on an exploratory clinical trial (ISRCTN10702895), assessing the efficacy and safety of 90 days of once-daily treatment with 90 mg N-Pep-12 on neurocognitive function and neurorecovery outcome in patients with post-stroke cognitive impairment against a control group. All participants performed two 32-channel QEEG in resting and active states at baseline (30-120 days after stroke) and 90 days later. Power spectral density on the alpha, beta, theta, delta frequency bands, delta/alpha power ratio (DAR), and (delta+theta)/(alpha+beta) ratio (DTABR) were computed and compared across study groups using means comparison and descriptive methods. Secondarily, associations between QEEG parameters and available neuropsychological tests were explored. RESULTS: Our analysis showed a statistically significant main effect of EEG segments (p<0.001) in alpha, beta, delta, theta, DA, and DTAB power spectral density. An interaction effect between EEG segments and time was noticed in the alpha power. There was a significant difference in theta spectral power between patients with N-Pep-12 supplementation versus placebo at 0.05 alpha level (p=0.023), independent of time points. CONCLUSION: A 90-day, 90 mg daily administration of N-Pep-12 had significant impact on some QEEG indicators in patients after supratentorial ischemic stroke, confirming possible enhancement of post-stroke neurorecovery. Further research is needed to consolidate our findings.
BACKGROUND: N-Pep-12 is a dietary supplement with neuroprotective and pro-cognitive effects, as shown in experimental models and clinical studies on patients after ischemic stroke. We tested the hypothesis that N-Pep-12 influences quantitative electroencephalography (QEEG) parameters in patients with subacute to chronic supratentorial ischemic lesions. METHODS: We performed secondary data analysis on an exploratory clinical trial (ISRCTN10702895), assessing the efficacy and safety of 90 days of once-daily treatment with 90 mg N-Pep-12 on neurocognitive function and neurorecovery outcome in patients with post-stroke cognitive impairment against a control group. All participants performed two 32-channel QEEG in resting and active states at baseline (30-120 days after stroke) and 90 days later. Power spectral density on the alpha, beta, theta, delta frequency bands, delta/alpha power ratio (DAR), and (delta+theta)/(alpha+beta) ratio (DTABR) were computed and compared across study groups using means comparison and descriptive methods. Secondarily, associations between QEEG parameters and available neuropsychological tests were explored. RESULTS: Our analysis showed a statistically significant main effect of EEG segments (p<0.001) in alpha, beta, delta, theta, DA, and DTAB power spectral density. An interaction effect between EEG segments and time was noticed in the alpha power. There was a significant difference in theta spectral power between patients with N-Pep-12 supplementation versus placebo at 0.05 alpha level (p=0.023), independent of time points. CONCLUSION: A 90-day, 90 mg daily administration of N-Pep-12 had significant impact on some QEEG indicators in patients after supratentorial ischemic stroke, confirming possible enhancement of post-stroke neurorecovery. Further research is needed to consolidate our findings.
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