Post-stroke Cognitive Impairment

Active, not recruiting

• Conditions: Cognitive Performance; First-ever Ischemic Stroke

• Registration Number: NCT05653141
• Lead Sponsor: Roza Umarova

Brief Summary

Present study aims to track the post-stroke cognitive trajectories and to investigate its inter-individual variability.

Detailed Description

The study aim is to establish a model capturing patients' inter-individual variability in susceptibility to stroke damage to predict stroke-induced cognitive trajectories. This is a prospective longitudinal observational national monocentric study for 6 years (recruitment during the first 3 years). The investigators perform comprehensive neuropsychological testing in i) acute stroke phase (0-10 days post-stroke), ii) sub-acute stroke phase (3 months post-stroke), and iii) chronic stroke phase (12 months and 3 years post-stroke). At each time point, cognitive performances as well as clinical and functional status will be assessed. Furthermore, the investigators will assess the proxies of cognitive reserve and the level of post-stroke physical activity.

Study Timeline

• Study Start: 2020-12-17
• Study First Submitted: 2022-11-23
• Study First Submitted QC: 2022-12-07
• Study First Posted: 2022-12-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2026-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

• Age ≥18 years old
• First-ever anterior circulation ischemic stroke confirmed by routine MRI
• Time of enrollment: ≤ 10 days from stroke onset.

Exclusion Criteria

• Previous stroke anamnestic or based on clinical imaging
• Additional stroke in posterior circulation
• Conditions that preclude the cognitive testing (e.g. delirium, intubation, reduced vigilance
• Neurological or psychiatric conditions that preclude the data interpretation (e.g. pre-stroke dementia, schizophrenia, brain tumor, regular intake of benzodiazepine, depression)
• MRI contraindication
• Native language other than German, French or Italian

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with delayed cognitive deterioration (DCD)	at 3 months, at 12 months and at 36 months post-stroke	The investigators will assess number of participants with deterioration of the cognitive performance in ≥2 cognitive domains on ≥ 1 Standard Deviation (1 SD).
Number of participants with delayed functional deterioration	at 3 months, at 12 months and at 36 months post-stroke	The investigators will assess number of participants with deterioration of functional disability will be defined as decrease in disability level to one point assessed via modified Rankin Scale (mRS, 0-6, whereas 0=no functional disability).

Secondary Outcome Measures

Name	Time	Method
Number of participants with post-stroke cognitive impairment	10 days post-stroke, 3 months, 12 months and at 36 months post-stroke	The investigators will assess number of participants with post-stroke cognitive impairment that is defined as at least moderate deficit (performance below -1.5 SD) in ≥ 2 cognitive domains. The cognitive performance across all basic cognitive domains is assessed using a standardized neuropsychological test battery with available normative data. The test battery includes tests from Consortium to Establish a Registry for Alzheimer's Disease (CERAD), Trail Making Test A + B, verbal fluency, alertness test, digit span (forward and backward), Bells test, and Montreal Cognitive Assessment.

Trial Locations

Locations (1)

Department of Neurology, Inselspital, University Hospital Bern, University of Bern; 🇨🇭 Bern, Switzerland