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

Sponsor
Universitair Ziekenhuis Brussel
Study ID
NCT06650436
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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

Study Details

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.

Key Dates

First listed
Oct 21, 2024
Start date
May 20, 2024
Status verified
Oct 2024
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: no delirium post-stroke
  • Arm: post-stroke delirium

Primary Outcome Measure

Post-stroke delirium [ Time Frame: first 72 hours after stroke symptom onset ]

Central Contacts

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