NCT05885295 The Imperial Comprehensive Cognitive Assessment in Cerebrovascular Disease (IC3)
| NCT ID | NCT05885295 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2028-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2021-12-01 with a primary completion date of 2028-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Frequently Asked Questions
Who can join the NCT05885295 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05885295 currently recruiting?
Yes, NCT05885295 is actively recruiting participants. Visit ClinicalTrials.gov or contact Imperial College London to inquire about joining.
Where is the NCT05885295 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05885295 clinical trial?
NCT05885295 is sponsored by Imperial College London. The trial plans to enroll 700 participants.
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