Supratentorial, radiologically confirmed ischemic stroke with the onset 30-120 days prior to screening Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Current interventions as of 02/06/2020:
The study is organised into three visits:
Visit 1 – Screening / Baseline - Study Day 0
Visit 2 – Efficacy / Safety - Study Day 90
Visit 3 – Efficacy / Safety
Sponsors
The Foundation for the Study of Neuroscience and Neuroregeneration (Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)
Eligibility
Sex/Gender
All
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 radiologically confirmed stroke in the 3 months preceding index stroke 6. Age between 18 and 80 years, inclusive 7. Signed informed consent form
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 < 1 year 5. Major drug dependency, including alcohol (in the investigator’s judgment) 6. Injury of writing hand influencing cognitive or other outcome measures, in the investigator’s judgment 7. Females who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cognitive function assessed using Montreal Cognitive Assessment (MoCA) at days 0, 90, 360 2. Emotional status assessed using Hospital Anxiety and Depression Scale at days 0, 90, 360 3. Cognitive function assessed using Digit Span (Wechsler adult intelligence scale – third edition at days 0, 90, 360 4. Cognitive function assessed using Color Trails Test at days 0, 90, 360 5. Cognitive function assessed using PSI (Processing Speed Index, Wechsler adult intelligence scale – third edition) at days 0, 90, 360 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety variables: 1.1. Adverse events/serious adverse events measured using a questionnaire at 90 and 360 days 1.2. Mortality reported at any time during the study 2. Subgroup analysis: 2.1. Eye movements assessed using a Tobii Pro TX300 eye tracking device and analyzed using Tobii Studio software at days 0, 90, 360 2.2. Brain electrical activity assessed using electroencephalography (EEG) and analyzed quantitatively using BrainAnalyzer software at days 0, 90, 360 | — |
Countries
Romania
Contacts
Public ContactOlivia Verisezan Rosu
Outcome results
None listed