Cognitive Recovery After Post Stroke Delirium [RECOVER] a Longitudinal Pilot Proof of Concept Study in Stroke Patients With/without Delirium
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Global post-stroke cognitive functioning
研究概览
简要总结
RECOVER is a Proof-of-Concept study on cognitive functioning following a longitudinal design with three measurements (during the acute- and post-acute phases of a stroke and a 3-month follow-up) and two equally-sized stroke patient groups: a post-stroke delirium(PSD), and a non-PSD group (control group). Cognitive functioning will be assessed using a multi-component neuropsychological assessment and tasked-based functional MRI (introducing a modified working memory task).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60 years
- •Ischemic stroke: Stroke Onset ≤ 96h, hospital admission ≤ 48h
- •NIHSS ≥ 1
- •Informed consent by patient or legal guardian
排除标准
- •Pre-existing conditions such as Dementia, psychiatric disorders (e.g., Depression, Schizophrenia)
- •MRI contraindication such as certain metal implants
- •Reduced consciousness, defined as Glasgow Coma Scale (GCS) ≤ 8
- •Delirium onset before study enrollment
结局指标
主要结局
Global post-stroke cognitive functioning
时间窗: 90 days
The primary endpoint will be a between-group comparison of the cognitive outcome, defined as global post-stroke cognitive functioning, at 3 months follow-up (S3), using multimodal data generated from the neuropsychological assessment and tasked-based fMRI.
次要结局
- Domain specific post-stroke cognitive functioning(90 days)
- Prediction of global post-stroke cognitive outcome(5 - 90 days)