IC3 protocol: a longitudinal observational study of cognition after stroke using novel digital health technology

Abstract

Introduction: 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 poststroke 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.

Methods and analysis: 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 use multiple validation approaches, and aim to recruit a large normative sample of age-matched, gender-matched and education-matched UK-based controls. Moreover, the IC3 assessment will be integrated within a larger prospective observational longitudinal clinical trial, where poststroke cognition will be examined in tandem with brain imaging and blood biomarkers to identify novel multimodal biomarkers of recovery after stroke. This study will enable deeper cognitive phenotyping of patients at a large scale, while identifying those with highest risk of progressive cognitive decline, as well as those with greatest potential for recovery.

Ethics and dissemination: This study has been approved by South West-Frenchay Research Ethics Committee (IRAS 299333) and authorised by the UK's Health Research Authority. Results from the study will be disseminated at conferences and within peer-reviewed journals.

Trial registration number: NCT05885295. Stage: Pre-results.

Keywords: Cognitive testing; biomarkers; cerebrovascular disease; observational study; stroke.

Figure 1

Infographic outlining the main specifications of the IC3 digital cognitive testing. IC3, Imperial Comprehensive Cognitive Assessment in Cerebrovascular Disease.

Figure 2

Example of cognitive summary report. Patient’s performance (in purple) is outlined against a normative group (in grey), corrected for device, age, gender and education. Each interval spacing represents 0.5 SD units (SD) such that this participant’s language comprehension performance was 1.5 SD below the mean normative performance. On the periphery of the spider diagram, the percentile score is shown for each task in purple, alongside a graded level of impairment.

Figure 3

(A) Overview of the main IC3 study and data collection. (B) Patient recruitment progress between February 2022 and March 2023. Cognitive assessments will be performed using the IC3 online assessment. Additional substudies will include blood biomarkers and MRI brain imaging. The 1-year follow-up is expected to take place between 12 months and 24 months poststroke.C3, Imperial Comprehensive Cognitive Assessment in Cerebrovascular Disease.