Supratentorial, radiologically confirmed ischemic stroke with the onset 30-120 days prior to screening Circulatory System
Conditions
Interventions
The synopsis of the study is organised in 3 visits:
Visit 1 – Screening / Baseline
Visit 2 – Efficacy / Safety - Day 30
Visit 3 – Efficacy / Safety - Day 90
No follow-up was performed after the 90
Sponsors
EN: The foundation for the study of neuroscience and neuroregeneration (RO: Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Stroke onset – 30-120 days prior to screening 2. Stroke is ischemic in origin, supratentorial, and radiologically confirmed (CT or MRI) 3. No significant pre-stroke disability (pre-stroke Modified Rankin Score of 0 or 1) 4. Goodglass and Kaplan Communication Scale Score of > 2 at screening 5. No other stroke in the 3 months preceding index stroke 6. Age between 18 and 80 years, inclusive
Exclusion criteria
Exclusion criteria: 1. Pre-existing and active major neurological disease 2. Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia (the short Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score >3) 3. Advanced liver, kidney, cardiac, or pulmonary disease 4. A terminal medical diagnosis consistent with survival 3 11. Glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cognitive function assessed using Montreal Cognitive Assessment (MoCA) (Nasreddine, 2005) at days 0, 30, 90 2. Emotional status assessed using Hospital Anxiety and Depression Scale (Zigmond, 1983) at days 0, 30, 90 3. Cognitive function assessed using Digit Span (Wechsler adult intelligence scale – third edition (Wechsler, 1997) at days 0, 30, 90 4. Cognitive function assessed using Color Trails Test (Posch, 2005) at days 0, 30, 90 5. Cognitive function assessed using PSI (Processing Speed Index, Wechsler adult intelligence scale – third edition) at days 0, 30, 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 02/04/2020: 1. Eye movements assessed using a Tobii Pro TX300 eye tracking device and analyzed using Tobii Studio software at days 0, 30, 90 2. Brain electrical activity assessed using electoencephalography (EEG) and analyzed quantitatively using BrainAnalyzer software at days 0, 30, 90 _____ Previous secondary outcome measures: 1. Eye movements assessed using a Tobii Pro TX300 eye tracking device and analyzed using Tobii Studio software at 30, 101 and 180 days 2. Brain electrical activity assessed using electoencephalography (EEG) and analyzed quantitatively using BrainAnalyzer software at 30, 101 and 180 days | — |
Countries
Romania
Contacts
Public ContactStefan Strilciuc
Outcome results
None listed