DEliriuM in STroke: the Link Between Stroke, Delirium and Long-term Cognitive Impairment

Condition(s) studied

Investigational drug(s) / intervention(s)

EEG: 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.

MRI: 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.

Depression screening and neuropsychological tests: 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

Study summary

Primary objective of this study:

determine whether PSD is a risk factor for PSCI, independent of brain frailty and premorbid cognitive functioning.

Secondary objectives:

1. to investigate the role of infarct location, imaging markers of brain frailty and brain network disintegration in the development of PSD;
2. to investigate the role of persistent brain network disintegration in the development of PSCI.

Eligibility

Primary outcome measure(s)

• Post-stroke delirium — first 72 hours after stroke symptom onset
  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.
• The role of brain network disintegration in post-stroke delirium: electrical analysis of the relative power in the alfa frequency band — first 72 hours after stroke symptom onset
  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.
• The role of brain network disintegration in post-stroke delirium: electrical analysis of the relative power in the beta frequency band — first 72 hours after stroke symptom onset
  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.
• The role of brain network disintegration in post-stroke delirium: electrical analysis of the relative power in the delta frequency band — first 72 hours after stroke symptom onset
  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.
• The role of brain network disintegration in post-stroke delirium: electrical analysis of the relative power in the theta frequency band — first 72 hours after stroke symptom onset
  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.
• The role of brain network disintegration in post-stroke delirium: electrical analysis of the relative power in the peak frequency band — first 72 hours after stroke symptom onset
  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.
• The role of brain network disintegration in post-stroke delirium: electrical analysis of the phase lag index (PLI) — first 72 hours after stroke symptom onset
  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.
• Post-stroke cognitive impairment — 3 months and 12 months after stroke symptom onset
  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.
• Post-stroke depression — 3 months and 12 months after stroke symptom onset
  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.
• Post-stroke depression — 3 months and 12 months after stroke symptom onset
  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.
• Markers of brain frailty — First 72 hours and 12 months after stroke symptom onset
  * visual rating of white matter hyperintensities using the Fazekas scale. * Visual rating of cerebral atrophy using the global cortical atrophy scale.

Trial sites (1)

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