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

NCT06650436 | Recruiting DMC

• 1 other identifier: 23375_DE_MIST
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Ischemic Stroke; Delirium; Cognitive Impairment

Keywords

Post stroke delirium; Post-stroke cognitive impairment; EEG; Delirium; Ischemic Stroke; Cognitive Impairment

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  First 72 hours and 12 months after stroke symptom onset

Secondary Outcomes (3)

• Key drivers of post-stroke delirium.

  12 months after stroke symptom onset

• Role infarct location

  12 months after stroke symptom onset

• Key drivers of post-stroke cognitive impairment.

  12 months after stroke symptom onset

Study Arms (2)

no delirium post-stroke

Diagnostic Test: EEG; Diagnostic Test: MRI; Diagnostic Test: Depression screening and neuropsychological tests

post-stroke delirium

Diagnostic Test: EEG; Diagnostic Test: MRI; Diagnostic Test: Depression screening and neuropsychological tests

Interventions

EEG DIAGNOSTIC_TEST

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.

no delirium post-stroke; post-stroke delirium

MRI DIAGNOSTIC_TEST

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.

no delirium post-stroke; post-stroke delirium

Depression screening and neuropsychological tests DIAGNOSTIC_TEST

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

no delirium post-stroke; post-stroke delirium

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients hospitalized at the stroke unit of UZ Brussel, who can be included within 72 hours after stroke symptom onset.

You may qualify if:

• years or older,
• admitted at stroke unit of UZ Brussel,
• ability to participate in cognitive assessments,
• fluency in Dutch or French,
• ability to undergo an EEG during the first 24 hours after onset of stroke symptoms,
• ability to undergo MRI of the brain.

You may not qualify if:

• epilepsy history,
• pre-existing, space occupying brain lesion (except small meningeoma),
• pregnancy or wish to become pregnant,
• severe language impairment or dementia impeding cognitive assessment, life expectancy of less than 1 year.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Vrije Universiteit Brussel: collaborator
• UMC Utrecht: collaborator

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Delirium; Cognitive Dysfunction

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Fenne Vandervorst, MD

CONTACT

024776801; fenne.vandervorst@uzbrussel.be

Karen Vandaele

CONTACT

024776801; karen.vandaele@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: October 21, 2024
• Study Start: May 20, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)