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临床试验/NCT05885295
NCT05885295招募中不适用

Understanding Factors Affecting Cognitive Function in Cerebrovascular Disease

Imperial College London1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
700
试验地点
1
主要终点
cognition

研究概览

简要总结

Stroke is a major cause of death and disability worldwide, frequently resulting in persistent cognitive deficits among survivors. These deficits negatively impact recovery and therapy engagement, and their treatment is consistently rated as high priority by stakeholders and clinicians. Although clinical guidelines endorse cognitive screening for post-stroke management, there is currently no gold standard approach for identifying cognitive deficits after stroke, and clinical stroke services lack the capacity for long-term cognitive monitoring and care. Currently available assessment tools are either not stroke-specific, not in-depth or lack scalability, leading to heterogeneity in patient assessments. To address these challenges, a cost-effective, scalable, and comprehensive screening tool is needed to provide a stroke-specific assessment of cognition. The current study presents such a novel digital tool, the Imperial Comprehensive Cognitive Assessment in Cerebrovascular Disease (IC3), designed to detect both domain-general and domain-specific cognitive deficits in patients after stroke with minimal input from a health professional. To ensure its reliability, we will utilise multiple validation approaches, and aim to recruit a large normative sample of age-, gender-, and education-matched UK-based controls. Moreover, the IC3 assessment will be integrated within a larger prospective observational longitudinal clinical trial, where post-stroke cognition will be examined in tandem with brain imaging and blood biomarkers to identify novel multimodal biomarkers of recovery after stroke. By leveraging this rich dataset, our study will allow more precise targeting of cognitive rehabilitation to stroke survivors that are most at risk of progressive cognitive decline and have the greatest potential for recovery.

详细描述

Aims and objectives

  1. Develop an adaptive, scalable, self-administered, digital comprehensive cognitive screening tool to detect cognitive impairments in patients with cerebrovascular disease. The IC3 will:

I. Detect both domain-general (e.g. executive function) and domain-specific (e.g. aphasia, apraxia, neglect) deficits post-stroke.

II. Allow monitoring to occur at scale, in a cost-efficient manner, as test administration can occur independent of trained professionals.

III. Minimise the effects of neglect or aphasia on cognitive assessments. IV. Have high test-re-test reliability for repeated-testing longitudinally. 2. Validate the IC3 against commonly used cognitive screening tools. 3. Apply the IC3 in a cohort of stroke survivors, as part of the main study, to map their trajectory of cognitive impairment over the course of the first year after stroke. 4. Identify novel biomarkers of cognitive outcome (cognitive scores at 1 year) and recovery trajectory through the main study using:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged > 18
  • Evidence of confirmed stroke (for patients)
  • Ability to concentrate for 15 minutes at a time to engage with cognitive testing
  • Exclusion Criteria for the main study:
  • Pre-stroke diagnosis of dementia
  • Severe visuo-spatial problems, fatigue, or mental health problems
  • Severe hearing impairment in the presence of reading comprehension impairment
  • Exclusion Criteria for the MRI imaging sub-study:
  • Pregnancy
  • Presence of metal implants
  • Claustrophobia

排除标准

  • 未提供

结局指标

主要结局

cognition

时间窗: 1 year after stroke

IC3-derived accuracy measures on cognitive testing Scale title: The Imperial Comprehensive Cognitive Assessment in Cerebrovascular Disease Impairment value defined as \<1.5 Standard Deviation Units below the age and education -matched control sample Lower values mean worse outcome

次要结局

  • NIHSS(1 year post stroke)
  • MOCA(1 year post stroke)
  • Lawton and Brody Instrumental activities of daily living (IADL)(1 year post stroke)
  • MRS(1 year post stroke)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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