Ischemic StrokeDE-MISTNCT06650436
DEliriuM in STroke: the Link Between Stroke, Delirium and Long-term Cognitive Impairment
An observational study of Ischemic Stroke and Delirium, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Delirium, Cognitive Impairment
- What is being tested?
- EEG, MRI and Depression screening and neuropsychological tests
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 20 May 2024to 31 May 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized at the stroke unit of UZ Brussel, who can be included within 72 hours after stroke symptom onset.
Who may be able to join
- 18 years or older,
- clinical diagnosis of first-ever ischemic stroke (onset <72h at time of inclusion),
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, 1090
Fenne Vandervorst, MD, 024776801, fenne.vandervorst@uzbrussel.be
About this study
Primary objective of this study:
determine whether PSD is a risk factor for PSCI, independent of brain frailty and premorbid cognitive functioning.
Secondary objectives:
- to investigate the role of infarct location, imaging markers of brain frailty and brain network disintegration in the development of PSD;
- to investigate the role of persistent brain network disintegration in the development of PSCI.
Read the detailed description
- Patient characteristics such as age, (premorbid) modified Rankin Scale (mRS) and stroke characteristics such as stroke severity (NIHSS) will be documented. There will be screened for preexisting cognitive decline (by using a Dutch shortened and validated version of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). Clinical assessments such as NIHSS and mRS will be repeated after 3 and 12 months, as part of regular care. Comorbid conditions will be documented during the whole duration of the study.
- Previous or concomitant use of drugs will be registered, in particular those known to affect cognitive function, such as anticholinergic drugs, analgo-sedatives or benzodiazepines.
- Delirium assessment during hospitalization: delirium assessment will be performed twice a day, at the beginning and ending of each day shift with a minimal interval of 5 hours between the two evaluations each day, during the first 72 hours after ischemic stroke onset. The length of the screening period is based on the results of a prospective observational study that showed that almost all of PSD cases occurred within 72 hours (98%). If a patient develops delirium during the first 72 hours after stroke onset, delirium monitoring will be continued until 4 negative screening tests are obtained (because of possible fluctuations of delirium signs) or until the end of the hospitalization. Delirium assessments will be performed by a trained nurse using the 4 'A's Test (4AT) and the Richmond Agitation and Sedation Scale (RASS). The RASS will be used to determine the type of delirium, with negative RASS scores indicating hypoactive delirium and a positive RASS score indicating hyperactive delirium.
- EEG recordings will be performed by a trained neurophysiology nurse, using 21 electrodes placed according to the 10-20 system, with 10 minutes eyes open and 10 minutes eyes closed, within one hour of the clinical evaluation during the hospitalization. The first EEG will be routinely recorded during the first 24 hours after stroke onset. A second EEG will be only be recorded in patients who develop PSD between 24 and 72 hours after stroke onset. EEG's recorded during hospitalization are considered standard of care. EEG recording will be repeated at 12 months.
- MRI of the brain will be performed during hospitalization (=standard of care) and 12 months after stroke onset. Standard acute stroke imaging will involve a 3-T MR scanner with sagittal 3DFLAIR (fluid-attenuated inversion recovery) sequence, T2 sequence fossa posterior with a slice thickness of 2mm, axial diffusion sequence (slice thickness 4mm), 3D-SWI (susceptibility weighted imaging) sequence (slice thickness 2mm) and 3D-QALAS sequence. Manual segmentation of the acute ischemic lesion will be performed on MRI scans of the brain, performed during hospitalization for IS. Patients without visible acute ischemic lesions on MRI will be excluded. Acute ischemic stroke lesions (AIL) are defined by the presence of a hyperintense MRI diffusion-weighted imaging (DWI) lesion with corresponding hypointensity in apparent diffusion coefficient map (ADC). The DWI and ADC images may also help to discriminate between new ischemic lesions and pre-existent white matter hyperintensities. Prior to performing the segmentations for the current study, the reviewer will delineate AIL on 10 scans twice with an interval of 1 month, with the aim to optimize intraobserver agreement. Visual rating of white matter hyperintensities (Fazekas scale) and cerebral atrophy (global cortical atrophy (GCA) scale) as markers of brain frailty.
- Cognitive and mood assessment: neuropsychological assessment will take place at 3 months and 12 months after the IS. A trained nurse will administer the Montreal Cognitive Assessment (MOCA, Dutch or French version) at these time intervals. She will be blinded for the initial occurrence of delirium. Depression screening will be performed at the same time intervals by using the Patient Health Questionnaire-2 and the Hospital Anxiety and Depression Scale (HADS) (in order to be able to compare with previously performed delirium studies).
- Conditions
- Ischemic Stroke, Delirium, Cognitive Impairment
- Being tested
- EEG, MRI, Depression screening and neuropsychological tests
- Keywords
- Post stroke delirium, Post-stroke cognitive impairment, EEG, Delirium, Ischemic Stroke, Cognitive Impairment
- Medical subject headings
- Ischemic Stroke, Delirium, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDiagnostic 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.
MRIDiagnostic 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.
Depression screening and neuropsychological testsDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| no delirium post-stroke | Not described Receives: Diagnostic Test: EEG; Diagnostic Test: MRI; Diagnostic Test: Depression screening and neuropsychological tests | |
| post-stroke delirium | Not described Receives: Diagnostic Test: EEG; Diagnostic Test: MRI; Diagnostic Test: Depression screening and neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First 72 hours and 12 months after stroke symptom onset
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: 12 months after stroke symptom onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start20 May 2024
- Primary completionMay 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, UMC Utrecht
- Responsible party
- Principal investigator, Fenne Vandervorst, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650436
- Sponsor's protocol ID
- 23375_DE_MIST
- Acronym
- DE-MIST
- Status last verified
- Oct 2024
- First submitted
- 13 May 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEliriuM in STroke: the Link Between Stroke, Delirium and Long-term Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06650436
- Acronym / sponsor ID
- DE-MIST / 23375_DE_MIST
- Conditions
- Ischemic Stroke, Delirium, Cognitive Impairment
- Keywords
- Post stroke delirium, Post-stroke cognitive impairment, EEG, Delirium, Ischemic Stroke, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel, UMC Utrecht
- Study start
- 20 May 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective of this study:
determine whether PSD is a risk factor for PSCI, independent of brain frailty and premorbid cognitive functioning.
Secondary objectives:
- to investigate the role of infarct location, imaging markers of brain frailty and brain network disintegration in the development of PSD;
- to investigate the role of persistent brain network disintegration in the development of PSCI.
Detailed description
- Patient characteristics such as age, (premorbid) modified Rankin Scale (mRS) and stroke characteristics such as stroke severity (NIHSS) will be documented. There will be screened for preexisting cognitive decline (by using a Dutch shortened and validated version of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). Clinical assessments such as NIHSS and mRS will be repeated after 3 and 12 months, as part of regular care. Comorbid conditions will be documented during the whole duration of the study.
- Previous or concomitant use of drugs will be registered, in particular those known to affect cognitive function, such as anticholinergic drugs, analgo-sedatives or benzodiazepines.
- Delirium assessment during hospitalization: delirium assessment will be performed twice a day, at the beginning and ending of each day shift with a minimal interval of 5 hours between the two evaluations each day, during the first 72 hours after ischemic stroke onset. The length of the screening period is based on the results of a prospective observational study that showed that almost all of PSD cases occurred within 72 hours (98%). If a patient develops delirium during the first 72 hours after stroke onset, delirium monitoring will be continued until 4 negative screening tests are obtained (because of possible fluctuations of delirium signs) or until the end of the hospitalization. Delirium assessments will be performed by a trained nurse using the 4 'A's Test (4AT) and the Richmond Agitation and Sedation Scale (RASS). The RASS will be used to determine the type of delirium, with negative RASS scores indicating hypoactive delirium and a positive RASS score indicating hyperactive delirium.
- EEG recordings will be performed by a trained neurophysiology nurse, using 21 electrodes placed according to the 10-20 system, with 10 minutes eyes open and 10 minutes eyes closed, within one hour of the clinical evaluation during the hospitalization. The first EEG will be routinely recorded during the first 24 hours after stroke onset. A second EEG will be only be recorded in patients who develop PSD between 24 and 72 hours after stroke onset. EEG's recorded during hospitalization are considered standard of care. EEG recording will be repeated at 12 months.
- MRI of the brain will be performed during hospitalization (=standard of care) and 12 months after stroke onset. Standard acute stroke imaging will involve a 3-T MR scanner with sagittal 3DFLAIR (fluid-attenuated inversion recovery) sequence, T2 sequence fossa posterior with a slice thickness of 2mm, axial diffusion sequence (slice thickness 4mm), 3D-SWI (susceptibility weighted imaging) sequence (slice thickness 2mm) and 3D-QALAS sequence. Manual segmentation of the acute ischemic lesion will be performed on MRI scans of the brain, performed during hospitalization for IS. Patients without visible acute ischemic lesions on MRI will be excluded. Acute ischemic stroke lesions (AIL) are defined by the presence of a hyperintense MRI diffusion-weighted imaging (DWI) lesion with corresponding hypointensity in apparent diffusion coefficient map (ADC). The DWI and ADC images may also help to discriminate between new ischemic lesions and pre-existent white matter hyperintensities. Prior to performing the segmentations for the current study, the reviewer will delineate AIL on 10 scans twice with an interval of 1 month, with the aim to optimize intraobserver agreement. Visual rating of white matter hyperintensities (Fazekas scale) and cerebral atrophy (global cortical atrophy (GCA) scale) as markers of brain frailty.
- Cognitive and mood assessment: neuropsychological assessment will take place at 3 months and 12 months after the IS. A trained nurse will administer the Montreal Cognitive Assessment (MOCA, Dutch or French version) at these time intervals. She will be blinded for the initial occurrence of delirium. Depression screening will be performed at the same time intervals by using the Patient Health Questionnaire-2 and the Hospital Anxiety and Depression Scale (HADS) (in order to be able to compare with previously performed delirium studies).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized at the stroke unit of UZ Brussel, who can be included within 72 hours after stroke symptom onset.
Key inclusion criteria (7 listed)
- 18 years or older,
- clinical diagnosis of first-ever ischemic stroke (onset <72h at time of inclusion),
- admitted at stroke unit of UZ Brussel,
- ability to participate in cognitive assessments,
- fluency in Dutch or French,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEGThe 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. | Diagnostic test | no delirium post-stroke, post-stroke delirium |
| MRIManual 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. | Diagnostic test | no delirium post-stroke, post-stroke delirium |
| Depression screening and neuropsychological testsScreening 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 | Diagnostic test | no delirium post-stroke, post-stroke delirium |
Primary outcome
Post-stroke delirium
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Key drivers of post-stroke delirium.
Time frame: 12 months after stroke symptom onset
Role infarct location
Time frame: 12 months after stroke symptom onset
Key drivers of post-stroke cognitive impairment.
Time frame: 12 months after stroke symptom onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Delirium, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fenne Vandervorst, MD (024776801, fenne.vandervorst@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-stroke delirium (time frame: first 72 hours after stroke symptom onset). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.