The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Observational)

Study Overview
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Brief Summary
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The study is aimed at the investigation of the association of biomarkers of circadian rhythms with sleep characteristics and stroke outcome in acute stroke patients. It is designed as an observational cohort study with the retrospective and prospective longitudinal arms.

Detailed Description
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In the retrospective arm of the study, the routinely collected data of patients admitted to the stroke unit with acute ischemic stroke (from 2018 till 2022) will be evaluated. In the prospective longitudinal arm, about 200-250 patients admitted to the Stroke Unit of one participating center will undergo examination including the assessment of medical records, stroke characteristics, sleep characteristics and blood sampling for the evaluation of genetic biomarkers of circadian rhythms within the first 2-3 days after admission.The assessment of stroke severity and functional deficit will be repeated at 10-14 days after stroke. The following associations will be assessed: the association of genetic biomarkers of circadian rhythms with stroke outcome (the difference in neurological and functional deficit from admission to 14th day after stroke), with stroke characteristics (stroke subtype and neuroimaging stroke parameters) and with sleep characteristics. the association of sleep characteristics with stroke outcome (the difference in neurological and functional deficit from admission to 14th day after stroke) and with stroke characteristics (stroke subtype and neuroimaging stroke parameters).

Official Title
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The Role of Circadian Factors in Regulation of Neuroplasticity in Ischemic Stroke (Observational)

Conditions
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Stroke, Ischemic, Sleep Disorder

Intervention / Treatment
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* Other: No intervention is planned


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute (symptom onset to admission <1 days) ischemic stroke ischemic stroke affecting the branches of anterior cerebral artery, middle cerebral artery and posterior cerebral artery age 18-80 years moderate or severe stroke (National Institutes of Health Stroke Scale, NIHSS>=5) intravascular stroke treatment with thrombolysis or thrombectomy leading to satisfactory reperfusion (if applicable) informed consent Exclusion Criteria: secondary parenchymal hemorrhage (>hemorrhage index -2) clinically unstable or life-threatening conditions known progressive neurological diseases known psychiatric diseases concomitant benzodiazepine medication drug or alcohol abuse pregnancy disability to participate in the study congestive heart failure with reduced ejection fraction (<=45%) or New York Heart Association (NYHA) classification III-IV functional class

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective cohort<br>Patients with acute ischemic stroke admitted to the Stroke Unit of one participating center in 2018-2022. The data collected within clinical routine will be analyzed including stroke characteristics at baseline and at discharge (10-14 days after admission), neuroimaging data, sleep characteristics (routine polygraphy study), heart rate variability, routine blood tests. | Other: No intervention is planned<br>* No intervention is planned<br>|
| Prospective cohort<br>Approximately 200-250 patients with acute ischemic stroke admitted to the Stroke Unit of one participating center in 2022-2024 will undergo the assessment of medical records, stroke characteristics, the assessment of sleep characteristics and blood sampling for the evaluation of genetic biomarkers of circadian rhythms at baseline (within 2-3 days of admission) and at 10-14 days (at discharge). | Other: No intervention is planned<br>* No intervention is planned<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the value of National Institutes of Health Stroke Scale from baseline to 14th day after inclusion | National Institutes of Health Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke, 0-42 scores, higher scores characterize worse impairment | From baseline to 14th day after treatment initiation | 
| Stroke-related disability assessed by the change in modified Rankin scale from baseline to 14th day after treatment initiation | values of modified Rankin scale (scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke, from 0 (no symptoms) to 6 (dead) points) | From baseline to 14th day after treatment initiation | 
| Stroke-related disability assessed by the change in Rivermead Mobility Index from baseline to 14th day after treatment initiation | a standardized scale used to assess mobility in patients with neurological deficits, a maximum of 15 points is possible; higher scores indicate better mobility performance | From baseline to 14th day after treatment initiation | 
| Stroke-related disability assessed by the change in Barthel Index from baseline to 14th day after treatment initiation | a common scale used to measure performance in activities of daily living, 0-100 scores, higher scores define better performance | From baseline to 14th day after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality assessed by Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index is a self-rated questionnaire which assesses sleep quality and disturbances over the last (previous) 1-month (a retrospective assessment) time interval, Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score indicating worse sleep quality | Baseline | 
| Sleepiness assessed by Epworth Sleepiness Scale | a common tool to assess sleepiness; 0-24 points, higher score indicate greater sleepiness | Baseline | 
| Fatigue assessed by Fatigue severity Scale | a common 9-item tool used to determine and quantify fatigue as subjective feeling of exhaustion, persisting lack of energy and rapid inanition, 9-63 points, higher score indicates more severe fatigue | Baseline | 
| Insomnia assessed by Insomnia severity index | a 7-item tool to assess the severity of insomnia, 0-5 points per each item, higher score indicates more severe insomnia | Baseline | 
| Chronotype assessed by Morningness-Eveningness Questionnaire | a common 19-item tool to estimate individual chronotype, a score ranging from 16 to 86; scores of 41 and below indicate evening types, scores of 59 and above indicate morning types, scores between 42-58 indicate intermediate types | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroplasticity, cognitive dysfunction, disability, circadian rhythm, functional deficit, stroke outcome, sleep-disordered breathing, heart rate variability