Post-stroke Cognitive Impairment (CogStroke)

December 7, 2022 updated by: Roza Umarova

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

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

335

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • Department of Neurology, Inselspital, University Hospital Bern, University of Bern
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study recuits patients hospitalized at the Department of Neurology of the University Hospital of Bern (Inselspital)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Stroke patients
Adults with first-ever anterior circulation stroke

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at 3 months, at 12 months and at 36 months post-stroke
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).
at 3 months, at 12 months and at 36 months post-stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 days post-stroke, 3 months, 12 months and at 36 months post-stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roza Umarova

Investigators

  • Principal Investigator: Roza M. Umarova, PD Dr., Department of Neurology, Inselspital, University Hospital Bern, University of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2020

Primary Completion (Anticipated)

October 31, 2026

Study Completion (Anticipated)

October 31, 2026

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Studien-Nr. 4599

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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