Stroke Clinical Trial
— IC3Official title:
Understanding Factors Affecting Cognitive Function in Cerebrovascular Disease
Verified date | May 2023 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | May 15, 2028 |
Est. primary completion date | May 15, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperial College London | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | cognition | 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 | 1 year after stroke | |
Secondary | MOCA | Clinically derived MOCA scores for cognition Scale title: The Montreal Cognitive Assessment Range 0-30. Lower values mean worse outcome. | 1 year post stroke | |
Secondary | NIHSS | NIH Stroke Scale Scale title: National Institute of Health Stroke Scale Range: 0-24 Lower values mean better outcome. | 1 year post stroke | |
Secondary | Lawton and Brody Instrumental activities of daily living (IADL) | Scale title: Lawton and Brody Instrumental Activities of Daily Living Source: Lawton, M.P., and Brody, E.M. "Assessment living." Gerontologist 9:179-186, (1969).
Range: 0-8 Lower values mean worse outcome. |
1 year post stroke | |
Secondary | MRS | Scale title: Modified Rankin Scale Range: 0-6 Lower values mean better outcome. | 1 year post stroke |
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