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NCT Number: NCT05653141

Post-stroke Cognitive Impairment

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Roza M. Umarova, PD Dr.

CONTACT

[email protected]

+41316327000

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of participants with delayed cognitive deterioration (DCD)

    Time frame: 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).

  2. Number of participants with delayed functional deterioration

    Time frame: 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 outcomes

  1. Number of participants with post-stroke cognitive impairment

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Gallucci, MSc

CONTACT

[email protected]

+41316641506

Roza M. Umarova, PD Dr.

CONTACT

[email protected]

+41316327000

Sponsors and collaborators

Lead sponsor

Roza Umarova

Other

Registry information

Official study title

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

Acronym: CogStroke

Important dates

Study start
2020
Primary completion
2026
Study completion
2029
First posted
Dec 16, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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