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
Conditions
Interventions
The synopsis of the study is organised in 4 visits:
1. Screening and Baseline - Study Day 0 (3-5 days post stroke)
2. Visit 1 - Study Day 30
3. Visit 2 - Study Day 60
4. Visit 3 - Study Day 90
No fol
therefore, colored infusion lines will be used for drug administration.
A set of envelopes for each patient enrolled should be distributed to the study nurse preparing the ready-to-use-infusion
Sponsors
The foundation for the study of neuroscience and neuroregeneration (SSNN)
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Language function assessed by Western Aphasia Battery (Kertesz, 1979) at days 0, 30, 60, 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 03/04/2023: 1. Stroke severity assessed by NIH Stroke Scale (http://www.nihstrokescale.org/) at days 0, 30, 60, 90 2. Functional outcome assessed by Modified Rankin Score (van Swieten J et al., 1988) at days 30, 60, 90 3. Activities of Daily Living assessed by Barthel Index (Mahoney et al., 1965) at days 30, 60, 90 _____ Previous secondary outcome measures: 1. Stroke severity assessed by NIH Stroke Scale (http://www.nihstrokescale.org/) at days 0, 30, 60, 90 2. Functional outcome assessed by Modified Rankin Score (van Swieten J et al., 1988) at days 0, 30, 60, 90 3. Activities of Daily Living assessed by Barthel Index (Mahoney et al., 1965) at days 0, 30, 60, 90 | — |
Countries
Romania
Contacts
Public ContactOlivia Verisezan Rosu
Outcome results
None listed