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Recruiting NCT05885295

The Imperial Comprehensive Cognitive Assessment in Cerebrovascular Disease (IC3)

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Trial Parameters

Condition Stroke
Sponsor Imperial College London
Study Type OBSERVATIONAL
Phase N/A
Enrollment 700
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-12-01
Completion 2028-05-15
Interventions
MRI brain, Blood tests, cognitive assessments

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * 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

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