Cerebrolysin's effects on language ability in stroke patients with non-fluent aphasia
Official title: Effects of Cerebrolysin on Language Ability in Non-fluent Aphasia Patients After Stroke: A Randomized, Placebo-controlled, Double-blinded, Single Center Study
Run by Yonsei University · NCT06897176 · Data updated 2026-11-12
This study tests if adding a medication called cerebrolysin to standard speech therapy can help stroke patients with non-fluent aphasia improve their language skills.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years to 90 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | March 12, 2025 |
| Main results expected | June 14, 2025 |
| Study ends | December 31, 2027 |
| Registry record updated | March 26, 2025 |
| Trial ID | NCT06897176 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are right-handed individuals aged 19 to 90 who have experienced their first ischemic or hemorrhagic stroke and are diagnosed with non-fluent aphasia.
✕Probably not a fit
Patients with multiple previous strokes, significant pre-existing neurogenic or psychiatric disorders, or allergies to cerebrolysin may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of cerebrolysin on language ability in patients suffering from non-fluent aphasia following a stroke. Participants are divided into two groups: one receiving standard speech therapy combined with cerebrolysin, and the other receiving only standard speech therapy as a control. The study aims to measure changes in language ability using the PK-WAB scores before and after treatment. It focuses on patients in the subacute phase of stroke, where language therapy is crucial for recovery.
Why it matters
Potential benefit: If successful, this study could enhance language recovery in stroke patients with non-fluent aphasia, potentially improving their quality of life.
How similar studies have gone: While there is ongoing research into treatments for aphasia, the specific use of cerebrolysin in this context is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
Seoul, South Korea Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.