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NCT05885295Recruiting

The Imperial Comprehensive Cognitive Assessment in Cerebrovascular Disease (IC3)

Understanding Factors Affecting Cognitive Function in Cerebrovascular Disease

Source: ClinicalTrials.gov · Last updated 1 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
700 (estimated)
First submitted
15 May 2023
Start date
1 Dec 2021
Primary completion date
15 May 2028
Lead sponsor
Imperial College London
NCT number
NCT05885295

What you commit to

  • Study type: Observational
  • Planned participants: 700
  • From 1 Dec 2021 to the primary completion date, 15 May 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Presence of metal implants

Other illness

  • Pre-stroke diagnosis of dementia
  • Severe hearing impairment in the presence of reading comprehension impairment

Other

  • Severe visuo-spatial problems, fatigue, or mental health problems
  • Pregnancy
  • Claustrophobia

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Imperial College London
Coordinator of this site? Confirm its status
LondonUnited KingdomRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.