Combined Neuropsychological, Neurophysiological and Psychophysiological Assessment of the Effects of N-Pep-12 on Neurorecovery in Patients after Ischemic Stroke

EN: The foundation for the study of neuroscience and neuroregeneration (RO: Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)0 sites121 target enrollmentFebruary 19, 2019

ConditionsSupratentorial, radiologically confirmed ischemic stroke with the onset 30-120 days prior to screening Circulatory System

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Supratentorial, radiologically confirmed ischemic stroke with the onset 30-120 days prior to screening
Sponsor: EN: The foundation for the study of neuroscience and neuroregeneration (RO: Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)
Enrollment: 121
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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)

Registry

who.int

Start Date

February 19, 2019

End Date

October 26, 2019

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

EN: The foundation for the study of neuroscience and neuroregeneration (RO: Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)

Eligibility 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

•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