Can Cerebrolysin improve aphasia after ischemic stroke?

Phase 4

Completed

• Conditions: Patients with Broca or mixed non-fluent aphasia post ischemic stroke with onset 3-5 days prior to inclusion; Circulatory System; Broca or mixed non-fluent aphasia following ischemic stroke

• Registration Number: ISRCTN54581790
• Lead Sponsor: The foundation for the study of neuroscience and neuroregeneration (SSNN)

Brief Summary

2024 Preprint results in https://doi.org/10.1101/2024.02.23.24303302 (added 19/08/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-29
• Study Completion: 2023-03-31
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 132

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
3. Inclusion in the study between 5 and 30 days post-stroke
4. Right-handedness
5. Romanian as language of daily use
6. Signed informed consent

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anguage function assessed by Western Aphasia Battery (Kertesz, 1979) at days 0, 30, 60, 90

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures as of 03/04/2023: <br><br>1. Stroke severity assessed by NIH Stroke Scale (http://www.nihstrokescale.org/) at days 0, 30, 60, 90<br>2. Functional outcome assessed by Modified Rankin Score (van Swieten J et al., 1988) at days 30, 60, 90<br>3. Activities of Daily Living assessed by Barthel Index (Mahoney et al., 1965) at days 30, 60, 90<br><br>_____<br><br>Previous secondary outcome measures:<br><br>1. Stroke severity assessed by NIH Stroke Scale (http://www.nihstrokescale.org/) at days 0, 30, 60, 90<br>2. Functional outcome assessed by Modified Rankin Score (van Swieten J et al., 1988) at days 0, 30, 60, 90<br>3. Activities of Daily Living assessed by Barthel Index (Mahoney et al., 1965) at days 0, 30, 60, 90