Status:
RECRUITING
Effects of Cerebrolysin on Language Ability in Non-fluent Aphasia Patients After Stroke: A Randomized, Placebo-controlled, Double-blinded, Single Center Study
Lead Sponsor:
Yonsei University
Conditions:
Stroke
Eligibility:
All Genders
19-90 years
Phase:
PHASE4
Brief Summary
" 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 ...
Eligibility Criteria
Inclusion
- Patients with a first-episodic of ischemic or hemorrhagic stroke
- Patients with lesions in the left supratentorial area confirmed by CT or MRI
- Subacute phase within one month of stroke onset
- Aged between 19 and 90 years
- Patients diagnosed with non-fluent aphasia through the Korean version of the Western Aphasia Battery
- Right-handed individuals assessed by the Edinburgh Handedness Inventory
- Individuals who voluntarily provided written consent for participation in the clinical trial, either personally or through their legal representative
- Native speakers of Korean
Exclusion
- Individuals with contraindications, including allergies to cerebrolysin
- Multiple previous episode of stroke that had been managed.
- Presence of significant pre-existing neurogenic disorders
- Presence of significant psychiatric disorders such as major depressive disorder, schizophrenia, bipolar disorder, or dementia
- History of alcohol or other substance abuse within 3 years of onset
- Presence of severe liver, kidney, heart, or respiratory diseases
- 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)
- Presence of an underlying medical condition with a life expectancy of less than 1 year
- Pregnant or breastfeeding individuals
- Participation in another therapeutic study
Key Trial Info
Start Date :
March 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06897176
Start Date
March 12 2025
End Date
December 31 2027
Last Update
March 26 2025
Active Locations (1)
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1
Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
Seoul, South Korea