ISRCTN54581790
Completed
Phase 4
Efficacy and safety of Cerebrolysin in the treatment of aphasia after acute ischemic stroke
The foundation for the study of neuroscience and neuroregeneration (SSNN)0 sites132 target enrollmentApril 29, 2020
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Patients with Broca or mixed non-fluent aphasia post ischemic stroke with onset 3-5 days prior to inclusion
- Sponsor
- The foundation for the study of neuroscience and neuroregeneration (SSNN)
- Enrollment
- 132
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
2024 Preprint results in https://doi.org/10.1101/2024.02.23.24303302 (added 19/08/2024)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 04/06/2020:
- •1\. Radiologically (CT or MRI) and clinically confirmed diagnosis of acute ischemic stroke in the left MCA territory
- •2\. Broca or mixed non\-fluent aphasia
- •3\. Inclusion in the study between 3 and 5 days post\-stroke
- •4\. Right\-handedness
- •5\. Romanian as language of daily use
- •6\. Signed informed consent
- •Previous inclusion criteria:
- •1\. Radiologically (CT or MRI) and clinically confirmed diagnosis of acute ischemic stroke in the left MCA territory
- •2\. Broca or mixed non\-fluent aphasia
Exclusion Criteria
- •1\. Prior symptomatic ischemic or hemorrhagic stroke
- •2\. Severe comprehension deficit that may compromise informed consent or understanding of instructions such as fluent aphasias (ex. Wernicke aphasia), or global aphasias
- •3\. Contraindications to MRI
- •4\. Preexisting neurodegenerative or psychiatric disease
- •5\. Epilepsy or EEG\-documented epileptic discharges
- •6\. Severe chronic renal or liver failure; (AST, ALT \> 4 times normal values, creatinine \> 4\)
- •7\. Life\-threatening diseases
- •8\. Auditory or visual deficits that cannot be corrected and might impair testing
Outcomes
Primary Outcomes
Not specified
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