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临床试验/ISRCTN10702895
ISRCTN10702895已完成4 期

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 个研究点目标入组 121 人开始时间: 2019年2月19日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
121

研究概览

简要总结

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)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 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

排除标准

  • 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

研究者

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

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