Post-stroke Cognitive Impairment

Cognitive Performance Clinical Trial

— CogStroke  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05653141
• Other study ID #: Studien-Nr. 4599
• Status: Recruiting
• Start date: December 17, 2020
• Est. completion date: October 31, 2026

Study information

• Verified date: December 2022
• Source: University Hospital Inselspital, Berne
• Contact: Roza M. Umarova, PD Dr.
• Phone: +41316327000
• Email: roza.umarova[@]insel.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 335
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Performance
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Switzerland	Department of Neurology, Inselspital, University Hospital Bern, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Roza Umarova

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with delayed cognitive deterioration (DCD)	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
Primary	Number of participants with delayed functional deterioration	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	Number of participants with post-stroke cognitive impairment	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