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

Launched by YONSEI UNIVERSITY · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called cerebrolysin on improving language skills in patients who have experienced a stroke and have difficulty speaking, known as non-fluent aphasia. The trial involves two groups of patients: one group will receive standard speech therapy along with cerebrolysin, while the other group will only receive speech therapy. The researchers will compare language abilities before and after treatment to see if cerebrolysin helps improve speech and communication.

To participate in this trial, you must be between 19 and 90 years old, have had your first stroke recently (within the last month), and have been diagnosed with non-fluent aphasia. You also need to be a native Korean speaker and right-handed. If you join the study, you can expect regular assessments of your language skills and support from healthcare professionals. It's important to note that certain individuals, such as those with specific allergies, severe medical conditions, or who are pregnant, cannot participate. This trial aims to gather more information on how cerebrolysin can aid in recovery after a stroke, especially in terms of improving language abilities.

Gender

ALL

Eligibility criteria

• 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