Can treatment with N-PEP-12 improve recovery after acute ischemic stroke?

Phase 4

Completed

• Conditions: Circulatory System; Supratentorial, radiologically confirmed ischemic stroke with the onset 30-120 days prior to screening

• Registration Number: ISRCTN10702895
• Lead Sponsor: EN: The foundation for the study of neuroscience and neuroregeneration (RO: Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33006057/ results (added 02/12/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34173086/ (added 28/06/2021) 2023 Other publications in https://doi.org/10.3390/medicina59081361 Correlating Eye-Tracking Fixation Metrics and Neuropsychological Assessment after Ischemic Stroke (added 05/03/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-19
• Study Completion: 2019-10-26
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 121

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

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.
8. Hemianopsia
9. Neglect
10. Myopia >3
11. Glaucoma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cognitive function assessed using Montreal Cognitive Assessment (MoCA) (Nasreddine, 2005) at days 0, 30, 90 <br>2. Emotional status assessed using Hospital Anxiety and Depression Scale (Zigmond, 1983) at days 0, 30, 90<br>3. Cognitive function assessed using Digit Span (Wechsler adult intelligence scale – third edition (Wechsler, 1997) at days 0, 30, 90<br>4. Cognitive function assessed using Color Trails Test (Posch, 2005) at days 0, 30, 90<br>5. Cognitive function assessed using PSI (Processing Speed Index, Wechsler adult intelligence scale – third edition) at days 0, 30, 90

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures as of 02/04/2020: <br>1. Eye movements assessed using a Tobii Pro TX300 eye tracking device and analyzed using Tobii Studio software at days 0, 30, 90<br>2. Brain electrical activity assessed using electoencephalography (EEG) and analyzed quantitatively using BrainAnalyzer software at days 0, 30, 90<br>_____<br>Previous secondary outcome measures:<br>1. Eye movements assessed using a Tobii Pro TX300 eye tracking device and analyzed using Tobii Studio software at 30, 101 and 180 days<br>2. Brain electrical activity assessed using electoencephalography (EEG) and analyzed quantitatively using BrainAnalyzer software at 30, 101 and 180 days