The Imperial Comprehensive Cognitive Assessment in Cerebrovascular Disease (IC3)

NCT05885295 | Recruiting

• 4 other identifiers: RGIT / R&D REF: 21HH7075MRC299333CPMS 50479
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Stroke (CVA) or TIA; Dementia, Vascular; Cerebrovascular Disorders; Small Vessel Cerebrovascular Disease; Cognitive Impairment

Keywords

dementia; MRI; blood biomarkers; neurofilament light; amyloid; tau; GFAP; white matter hyper intensity; micro bleed; small vessel disease; cognitive impairment; vascular dementia; stroke; aphasia; neglect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• MOCA

  1 year post stroke

• NIHSS

  1 year post stroke

• Lawton and Brody Instrumental activities of daily living (IADL)

  1 year post stroke

• MRS

  1 year post stroke

Study Arms (2)

Patient

Patient with stroke

Diagnostic Test: MRI brain, Blood tests, cognitive assessments

Controls

Age-matched controls

Diagnostic Test: MRI brain, Blood tests, cognitive assessments

Interventions

MRI brain, Blood tests, cognitive assessments DIAGNOSTIC_TEST

observational study examining cognition post stroke using behavioural tests, MRI brain and blood tests

Controls; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with stroke

You may qualify if:

• Aged \> 18
• Evidence of confirmed stroke (for patients)
• Ability to concentrate for 15 minutes at a time to engage with cognitive testing

You may not qualify if:

• 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
• Presence of metal implants
• Claustrophobia

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, w12 0NN, United Kingdom

RECRUITING

Related Publications (1)

• Gruia DC, Trender W, Hellyer P, Banerjee S, Kwan J, Zetterberg H, Hampshire A, Geranmayeh F. IC3 protocol: a longitudinal observational study of cognition after stroke using novel digital health technology. BMJ Open. 2023 Nov 24;13(11):e076653. doi: 10.1136/bmjopen-2023-076653.

  PMID: 38000822 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Stroke; Dementia, Vascular; Cerebrovascular Disorders; Cerebral Small Vessel Diseases; Cognitive Dysfunction; Dementia; Charcot-Marie-Tooth disease, Type 1F; Alzheimer Disease; Pick Disease of the Brain; Aphasia

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases; Frontotemporal Dementia; Frontotemporal Lobar Degeneration; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 1, 2023
• Study Start: December 1, 2021
• Primary Completion (Estimated): May 15, 2028
• Study Completion (Estimated): May 15, 2028
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

GB (1)