Cerebrolysin's effects on language ability in stroke patients with non-fluent aphasia
Effects of Cerebrolysin on Language Ability in Non-fluent Aphasia Patients After Stroke: A Randomized, Placebo-controlled, Double-blinded, Single Center Study
PHASE4 · Yonsei University · NCT06897176
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 19 Years to 90 Years |
| Sex | All |
| Sponsor | Yonsei University (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06897176 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul
- Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine — Seoul, South Korea (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke