IC3 Protocol: A novel digital health method for monitoring cognition after stroke

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 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. 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 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. This study will enable deeper cognitive phenotyping of patients at a large scale, whilst 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 approval by South West - Frenchay Research Ethics Committee (IRAS 299333), and authorized by the UK's Health Research Authority. Study registration. The study is registered as an observational trial under [NCT05885295][1]. ### Competing Interest Statement PH is the co-founder and chief executive of H2 Cognitive Designs LTD, for which he receives remuneration. HZ has served at scientific advisory boards and/or as a consultant for a number of commercial companies and is a co-founder of Brain Biomarker Solutions. ### Clinical Protocols ### Funding Statement This research is funded by MRC MR/T001402/1. Infrastructure support was provided by the NIHR Imperial Biomedical Research Centre and the NIHR Imperial Clinical Research Facility. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: South West, Frenchay Research Ethics Committee (IRAS 299333), of Imperial College London gave ethical approval for this work. The study was also authorized by the UK's Health Research Authority. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes As the current work only discusses the study's protocol, there is no data available. The authors, however, are happy to share more information about the IC3 software upon reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05885295&atom=%2Fmedrxiv%2Fearly%2F2023%2F08%2F24%2F2023.08.23.23294469.atom