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

NCT06650436 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2024-10-21

No results posted yet for this 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.

Conditions

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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

Sponsors & Collaborators

  • Vrije Universiteit Brussel

    collaborator OTHER

  • UMC Utrecht

    collaborator OTHER

  • Universitair Ziekenhuis Brussel

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06650436 on ClinicalTrials.gov