An observational study in Ischemic Stroke, Delirium and Cognitive Impairment, sponsored by Universitair Ziekenhuis Brussel. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Universitair Ziekenhuis Brussel · Observational
Primary objective of this study:
determine whether PSD is a risk factor for PSCI, independent of brain frailty and premorbid cognitive functioning.
Secondary objectives:
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 150 is close to the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients hospitalized at the stroke unit of UZ Brussel, who can be included within 72 hours after stroke symptom onset.
Exclusion Criteria:
Diagnostic Test: EEG · Diagnostic Test: MRI · Diagnostic Test: Depression screening and neuropsychological tests
Diagnostic Test: EEG · Diagnostic Test: MRI · Diagnostic Test: Depression screening and neuropsychological tests
The phase lag index will be used to assess functional connectivity between time series based on the consistency with which one signal is leading or lagging with respect to another signal.The PLI characterizes the asymmetry in the distribution of instantaneous phase differences between signals. If such an asymmetry is present, a phase coupling is assumed between signals, reflecting synchronized activity. Importantly, zero-phase coupling is discarded in the PLI as this may represent activity from common sources picked up at different electrodes. Based on the MST, network measures can be calculated. It is a measure of network efficiency. Leaf fraction quantifies the fraction of nodes in the whole network that have only one connecting edge, which is a measure of network integration.
Manual segmentation of the acute ischemic lesion will be performed on MRI of the brain. Support vector regression-based lesion symptom mapping (SVR-LSM) will be performed to determine the association between AIL location and PSD. We will also perform an assumption-free region of interest (ROI)-based analysis by using support vector regression. The ROIs will be determined by the AAL atlas and ICBM-DTI-81 white matter tract atlas in MNI-152 space. The MRI's will be performed within 72 hours of the stroke onset with a follow-up of 12 months.
Screening post-stroke delirium (during first 72hours after stroke symptom onset): 4AT test score: 0-12 (\>/= 4: diagnosis of (post-stroke) delirium) RASS score: from -5 until +4 Screening post-stroke cognitive impairment (3months, 12 months): MOCA score: 0-30 Screening post-stroke depression: Patient Health Questionnaire-2: score 0-6 Hospital Anxiety and Depression Scale: score 0-21Anxiety and 0-21Depression
Post-stroke delirium
Firstly using the 4 A's test (4AT) to screen for delirium. This score can go from 0 which indicates no suspicion of delirium; to a score higher than 4 which does indicates a higher suspicion of delirium. Then we'll further analyse the type of delirium using the Richmond Agitation-Sedation Scale (RASS). This scale has 2 types of scores, the first one being the negative scores (-5 -\> -1) that fits a hypoactive presentation of delirium. 0 is a normal score, indicating an alert and calm patient. The positive scores (1 -\> 4) are administered in case of hyperactive presentations of delirium.
Time frame: first 72 hours after stroke symptom onset
The role of brain network disintegration in post-stroke delirium: electrical analysis of the relative power in the alfa frequency band
To further understand the underlying brain activity during post-stroke delirium we'll perform an additional electroencephalogram (EEG) to look at potential deviations in the brain activity that could be connected to this clinical presentation. We'll specifically look at the relative power in the alfa frequency band.
Time frame: first 72 hours after stroke symptom onset
The role of brain network disintegration in post-stroke delirium: electrical analysis of the relative power in the beta frequency band
To further understand the underlying brain activity during post-stroke delirium we'll perform an additional electroencephalogram (EEG) to look at potential deviations in the brain activity that could be connected to this clinical presentation. We'll specifically look at the relative power in the beta frequency band.
Time frame: first 72 hours after stroke symptom onset
The role of brain network disintegration in post-stroke delirium: electrical analysis of the relative power in the delta frequency band
To further understand the underlying brain activity during post-stroke delirium we'll perform an additional electroencephalogram (EEG) to look at potential deviations in the brain activity that could be connected to this clinical presentation. We'll specifically look at the relative power in the delta frequency band.
Time frame: first 72 hours after stroke symptom onset
The role of brain network disintegration in post-stroke delirium: electrical analysis of the relative power in the theta frequency band
To further understand the underlying brain activity during post-stroke delirium we'll perform an additional electroencephalogram (EEG) to look at potential deviations in the brain activity that could be connected to this clinical presentation. We'll specifically look at the relative power in the theta frequency band.
Time frame: first 72 hours after stroke symptom onset
The role of brain network disintegration in post-stroke delirium: electrical analysis of the relative power in the peak frequency band
To further understand the underlying brain activity during post-stroke delirium we'll perform an additional electroencephalogram (EEG) to look at potential deviations in the brain activity that could be connected to this clinical presentation. We'll specifically look at the relative power in the peak frequency band.
Time frame: first 72 hours after stroke symptom onset
The role of brain network disintegration in post-stroke delirium: electrical analysis of the phase lag index (PLI)
To further understand the underlying brain activity during post-stroke delirium we'll perform an additional electroencephalogram (EEG) to look at potential deviations in the brain activity that could be connected to this clinical presentation. We'll specifically look at the phase lag index (PLI) to assess functional connectivity between time series based on the consistency with which one signal is leading or lagging with respect to another signal. The PLI characterizes the assymetry in the distribution of instantaneous phase differences between signals.
Time frame: first 72 hours after stroke symptom onset
Post-stroke cognitive impairment
Using the Montreal Cognitive Assessment (MOCA) score. This is a maximum score of 30 points where a normal cognition is linked to a score of 26 or higher.
Time frame: 3 months and 12 months after stroke symptom onset
Post-stroke depression
Using the Patient Health Questionnaire-2 (PHQ-2). These scores range from 0 to 6. A score of 3 or higher indicates that major depressive disorder is likely.
Time frame: 3 months and 12 months after stroke symptom onset
Post-stroke depression
Using the Hospital Anxiety and Depression Scale (HADS). This test has a maximum of 21 points. Between 8 and 10 there is a possibility that the patient suffers from anxiety or depression. Between 11 and 21 it is likely that the patient suffers from anxiety or depression.
Time frame: 3 months and 12 months after stroke symptom onset
Markers of brain frailty
* visual rating of white matter hyperintensities using the Fazekas scale. * Visual rating of cerebral atrophy using the global cortical atrophy scale.
Time frame: First 72 hours and 12 months after stroke symptom onset
Key drivers of post-stroke delirium.
To determine if there are neuro-electrical key drivers of post-stroke delirium. We'll combine looking at impairment of functional brain connectivity strength and network disintegration.
Time frame: 12 months after stroke symptom onset
Role infarct location
To investigate the role of infarct location on development of post-stroke delirium. We'll analyse the anatomical location of the infarction to look if there is a connection betweet certain locations and the presence of post-stroke delirium in the patient.
Time frame: 12 months after stroke symptom onset
Key drivers of post-stroke cognitive impairment.
After determining if there is cognitive impairment, using the Montreal Cognitive Assessment (MOCA) score, we'll look at the electrical brain activity (both looking at persistent impairment of functional brain connectivity strength and network disintegration).
Time frame: 12 months after stroke symptom onset
Plan to share: No
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Universitair Ziekenhuis Brussel