Post-stroke Cognitive Impairment

Официальное название

Prediction of Post-stroke Cognitive Decline and Dementia: Impact of Cognitive Reserve and Post-stroke Life Style

Обзор

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

Подробное описание

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.

Analyses of the longitudinal dataset, including follow-up assessments up to 36 months post-stroke, indicated an attrition rate of up to 50%, partly attributable to post-stroke mortality. This level of attrition resulted in a substantial reduction in effective sample size and, consequently, insufficient statistical power for the planned prediction models and independent validation analyses. In particular, the reduced number of complete cases limited the robustness and generalizability of the findings. Therefore, following a recruitment pause on 02.10.2023, patient recruitment was resumed on 05.08.2025 after securing additional funding and dedicated study personnel to ensure adequate sample size for model development and validation.

Первичные конечные точки

• Number of participants with delayed cognitive deterioration (DCD) [Срок оценки: at 3 months, at 12 months and at 36 months post-stroke]
• Number of participants with delayed functional deterioration [Срок оценки: at 3 months, at 12 months and at 36 months post-stroke]

Вторичные конечные точки (1)

• Number of participants with post-stroke cognitive impairment [Срок оценки: 10 days post-stroke, 3 months, 12 months and at 36 months post-stroke]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 1 центр

• Department of Neurology, Inselspital, University Hospital Bern, University of Bern — Bern

Публикации

• Umarova RM. Adapting the concepts of brain and cognitive reserve to post-stroke cognitive deficits: Implications for understanding neglect. Cortex. 2017 Dec;97:327-338. doi: 10.1016/j.cortex.2016.12.006. Epub 2016 Dec 16. PMID 28049565
• Gallucci L, Sperber C, Monsch AU, Kloppel S, Arnold M, Umarova RM. Improving diagnostic accuracy of the Montreal Cognitive Assessment to identify post-stroke cognitive impairment. Sci Rep. 2024 Aug 29;14(1):20125. doi: 10.1038/s41598-024-71184-x. PMID 39209968

Идентификаторы

NCT: NCT05653141 · Studien-Nr. 4599

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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