IC3 protocol: a longitudinal observational study of cognition after stroke using novel digital health technology.
Dragos-Cristian Gruia, William Trender, Peter Hellyer...
https://pubmed.ncbi.nlm.nih.gov/38000822Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID05885295
Understanding Factors Affecting Cognitive Function in Cerebrovascular Disease
Led by Imperial College London · Updated on 2023-06-01
700
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Stroke is a major cause of death and long-term disability worldwide, often leading to ongoing cognitive problems that affect recovery and therapy engagement. There is no widely accepted gold standard for identifying cognitive deficits after stroke, and many clinical services lack resources for long-term cognitive monitoring. This research aims to develop and validate a digital cognitive screening tool called the Imperial Comprehensive Cognitive Assessment in Cerebrovascular Disease (IC3) to detect both general and specific cognitive impairments in stroke survivors with minimal input from health professionals. The study also seeks to identify new brain imaging and blood biomarkers linked to cognitive recovery after stroke. The IC3 assessment includes 22 brief tasks covering various cognitive domains and several validated questionnaires, taking about 60-70 minutes to complete on any modern device via a web browser. This tool is designed to be scalable, cost-effective, and usable both in clinical settings and at home, making it accessible for patients with physical disabilities. The study is a prospective observational trial recruiting 300 stroke patients and age-matched healthy controls, with repeated cognitive and psychosocial assessments at baseline, 3, 6, and 12 months. Additional sub-studies include brain MRI scans and blood biomarker sampling at multiple time points to explore links to cognitive outcomes. Participants will complete cognitive tasks and questionnaires remotely or in clinic, with results compared to normative data from healthy controls. Brain imaging and blood samples will be collected to assess structural and biochemical markers related to stroke recovery. The main outcome measured is cognition one year after stroke, alongside other functional and neurological scales. Safety and eligibility will be carefully monitored, and participants can contribute to understanding how best to detect and track cognitive changes post-stroke over time.
CONDITIONS
Brief Title
The Imperial Comprehensive Cognitive Assessment in Cerebrovascular Disease (IC3)
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Aged over 18 years
- Evidence of confirmed stroke (for patients)
- Ability to concentrate for 15 minutes at a time to engage with cognitive testing
You will not qualify if you...
- Pre-stroke diagnosis of dementia
- Severe visuo-spatial problems, fatigue, or mental health problems
- Severe hearing impairment in the presence of reading comprehension impairment
- Pregnancy (for MRI sub-study)
- Presence of metal implants (for MRI sub-study)
- Claustrophobia (for MRI sub-study)
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline and up to 12 months
Participants undergo cognitive assessments, MRI brain imaging, and blood tests to evaluate cognitive function and biomarkers after stroke.
Assessments at baseline, 3 months, 6 months, and 12 months
Long-term Monitoring
Duration - 12 months
Participants are monitored longitudinally to track cognitive impairment and recovery trajectory over the first year after stroke.
Repeated assessments at 3, 6, and 12 months post-baseline
Trial Site Locations
Total: 1 location
1
Imperial College London
London, United Kingdom, w12 0NN
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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