Clinical trial NCT05653141: Post-stroke Cognitive Impairment
Official title: Prediction of Post-stroke Cognitive Decline and Dementia: Impact of Cognitive Reserve and Post-stroke Life Style
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: First-ever Ischemic Stroke
Cognitive Performance
Keywords: Ischemic stroke
Cognitive reserve
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study recuits patients hospitalized at the Department of Neurology of the University Hospital of Bern (Inselspital)

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with delayed cognitive deterioration (DCD)
timeFrame: at 3 months, at 12 months and at 36 months post-stroke
measure: Number of participants with delayed functional deterioration
timeFrame: at 3 months, at 12 months and at 36 months post-stroke
Secondary outcomes:
measure: Number of participants with post-stroke cognitive impairment
timeFrame: 10 days post-stroke, 3 months, 12 months and at 36 months post-stroke
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Neurology, Inselspital, University Hospital Bern, University of Bern
Study officials:
affiliation: Department of Neurology, Inselspital, University Hospital Bern, University of Bern
name: Roza M. Umarova, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.