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Effects of Cerebrolysin on Language Ability in Non-fluent Aphasia Patients After Stroke: A Randomized, Placebo-controlled, Double-blinded, Single Center Study

RecruitingPhase 4Ages 19 Years - 90 YearsAllYonsei University
NCT06897176 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

" This study aims to measure changes in language ability after adding cerebrolysin to standard treatment for non-fluent aphasia patients with post-stroke language impairment. The patients are divided into two groups: the experimental group, which receives a combination of standard treatment (speech therapy) and cerebrolysin, and the control group, which only receives standard treatment (speech therapy). By comparing the PK-WAB scores before and after drug administration, the study seeks to analyze the impact of cerebrolysin on language improvement. According to various stroke registries, 15-42% of patients in the subacute phase of stroke and 25-50% of patients with chronic stroke show symptoms of aphasia. Language therapy for stroke-related aphasia has become increasingly important due to its association with prolonged hospitalization, increased healthcare costs, mortality, and other neg

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients with a first-episodic of ischemic or hemorrhagic stroke 2. Patients with lesions in the left supratentorial area confirmed by CT or MRI 3. Subacute phase within one month of stroke onset 4. Aged between 19 and 90 years 5. Patients diagnosed with non-fluent aphasia through the Korean version of the Western Aphasia Battery 6. Right-handed individuals assessed by the Edinburgh Handedness Inventory 7. Individuals who voluntarily provided written consent for participation in the clinical trial, either personally or through their legal representative 8. Native speakers of Korean Exclusion Criteria: 1. Individuals with contraindications, including allergies to cerebrolysin 2. Multiple previous episode of stroke that had been managed. 3. Presence of significant pre-existing neurogenic disorders 4. Presence of significant psychiatric disorders such as major depressive disorder, schizophrenia, bipolar disorder, or dementia 5. History of alcohol or other substance abuse within 3 years of onset 6. Presence of severe liver, kidney, heart, or respiratory diseases 7. Medical findings from diagnostic tests indicating any of the following conditions (Total serum bilirubin \> 4mg/dL, alkaline phosphatase \> 250 U/L, SGOT/AST \> 150 U/L. SGPT/ALT \> 150 U/L., or creatinine \>3.5 mg/dL) 8. Presence of an underlying medical condition with a life expectancy of less than 1 year 9. Pregnant or breastfeeding individuals 10. Participation in another therapeutic study
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What it tests

  • Cerebrolyisin
  • Placebo
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Where

1 site
Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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