ISRCTN15764675进行中（未招募）4 期
Combined neuropsychological, neurophysiological and psychophysiological assessment of the effects of N-Pep-12 on neurorecovery in patients after ischemic stroke - N-Pep-12 Extension
The Foundation for the Study of Neuroscience and Neuroregeneration (Fundatia pentru Studiul Nanoneurostiintelor si Neuroregenerarii)0 个研究点目标入组 107 人开始时间: 2020年4月29日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 107
研究概览
简要总结
暂无简介。
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 radiologically confirmed stroke in the 3 months preceding index stroke
- •6. Age between 18 and 80 years, inclusive
- •7. Signed informed consent form
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
研究者
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