Post-stroke Cognitive Impairment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoza Umarova
About this trial
Present study aims to track the post-stroke cognitive trajectories and to investigate its inter-individual variability.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years old
First-ever anterior circulation ischemic stroke confirmed by routine MRI
Time of enrollment: ≤ 10 days from stroke onset.
Disqualifiers
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)
Trial population
The study recuits patients hospitalized at the Department of Neurology of the University Hospital of Bern (Inselspital)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 1 trial groupGroup A: Stroke patients
Trial outcomes
Primary outcomes
1
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).
Time frame
at 3 months, at 12 months and at 36 months post-stroke2
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).
Time frame
at 3 months, at 12 months and at 36 months post-strokeSecondary outcomes
1
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.
Time frame
10 days post-stroke, 3 months, 12 months and at 36 months post-strokeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Roza Umarova
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Sponsor institution
Source ClinicalTrials.gov