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Better Understanding of Fatigue After STroke

Better Understanding of Fatigue After STroke

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06292377
Enrollment
250
Registered
2024-03-05
Start date
2024-06-07
Completion date
2027-12-31
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

Stroke is worldwide the second most common cause of death following heart attack and the leading cause of disability. Post-stroke fatigue (PSF) is a common complication after stroke and can be defined as 'an overwhelming exhaustion or tiredness, not related to exertion, which does not typically improve with rest'. Fatigue following stroke can be divided into early (\< 3 months) and late (\> 3 months) fatigue. PSF can have a considerable impact on a person's everyday activities and quality of life, participation in the rehabilitation process and levels of caregiver burden. Yet no efficient treatment exists to prevent or cure PSF because the pathophysiology remains unclear and seems to be multifaceted. Autonomic dysfunction is a common complication after stroke, associated with higher morbidity and mortality. An easy tool to measure the function of the autonomic nervous system (ANS) is heart rate variability (HRV), which is defined as the beat-to-beat variation of the heart rate (= interbeat interval (IBI)). It is the result of alterations in the sympathetic and parasympathetic nervous system. In recent systematic reviews, authors stipulate that HRV can be regarded as a prognostic factor for short- and long-term stroke outcomes. HRV can be derived from 24 hours, 5 minutes (short-term) and \< 5 minutes (ultra-short-term) measurements by applying time-domain and frequency-domain indices. Autonomic dysfunction has been related to chronic fatigue syndrome, in addition to fatigue in multiple sclerosis, Parkinson's disease and myasthenia gravis. However, to the best of our knowledge, the relationship between autonomic dysfunction and PSF has not yet been fully investigated. Fatigue is also common in cardiovascular diseases, especially in patients with heart failure (HF). HF can contribute to fatigue after stroke, independently of stroke. Cardiac complications after acute ischemic stroke (AIS), such as arrhythmias, cardiac dysfunction and myocardial injury, are frequent. The so-called 'stroke-heart syndrome', a concept introduced in 2018, describes a broad spectrum of cardiac changes observed in 10-20% of patients with AIS within the first month after stroke onset, with a peak in the first 72 hours. A dysregulation in the neural-cardiac control after stroke is suspected to be the cause of the cascade leading to cardiac complications, in which autonomic dysfunction and inflammation seem to be part of the underlying mechanism. Based on previous studies and by analogy with other neurological diseases, the investigators hypothesize that autonomic dysfunction following AIS contributes to PSF and that patients presenting heart failure as a complication following AIS have an increased risk of PSF. To confirm this hypothesis, the investigators will conduct a prospective, interventional study where patients who are hospitalized at the Stroke Unit, within 72 hours after stroke symptom onset, will be included. Evaluation will take place of (a) the relationship between autonomic dysfunction (HRV) and early and late PSF, and of (b) the relationship between cardiac dysfunction and early PSF and late PSF. There will also be an investigation into following elements: * the association between early and late PSF and (a) certain inflammatory markers at admission (CRP, NLR), (b) stroke localization and (c) baseline imaging markers of brain frailty. * the role of pre-existing fatigue + pre-existing or post-stroke newly diagnosed cognitive impairment, depression and sleep disturbances on the course of PSF.

Interventions

DIAGNOSTIC_TESTECG

An electrocardiogram (ECG) is a simple, non-invasive test that records the electrical activity of the heart.

DIAGNOSTIC_TESTTransthoracic echography (TTE)

A transthoracic echocardiogram (TTE) is a test that uses ultrasound (sound waves) to create images of the heart.

DIAGNOSTIC_TESTBlood sampling

Blood sampling will include: complete blood count, serum creatinine and electrolytes, liver enzymes, fast lipid profile, glucose, HbA1C, thyroid-stimulating hormone (TSH), CRP, iron status, cardiac troponin (cTnT), N-terminal pro-brain natriuretic peptide (NT-proBNP).

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 * First-ever (suspicion of) ischemic stroke based on clinical examination and/or brain imaging * Onset \< 72h at time of inclusion * Admitted at the stroke unit of CHU Brugmann and UZ Brussel * Ability to participate in assessment of fatigue, cognitive, mood and sleep disturbances * Ability to undergo MRI of the brain

Exclusion criteria

* Unable to speak French or Dutch * Pre-existing stroke or other structural brain lesion * Life expectancy \< 1 year * Severe language impairment or dementia impeding assessment of fatigue, cognitive, mood and sleep disturbances * Pregnancy or wish to become pregnant

Design outcomes

Primary

MeasureTime frameDescription
Heart rate variability (HRV)Baseline (hospital admission)Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.
Transthoracic echography (TTE)Baseline (hospital admission)Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).
Fatigue Severity Scale (FSS-7)3 months after baselineThe 7 items Fatigue Severity Scale (FSS-7) is a method of evaluating the impact of fatigue. The FSS-7 is a questionnaire with 7 statements rated from 1 (disagree) to 7 (agree). No official cut-off has been established, but most studies adopt the approach of using the average score: an average of ≥4 suggests clinically relevant fatigue, while an average \<4 indicates low to moderate fatigue.
N-terminal pro-brain natriuretic peptide (NT-proBNP)Baseline (hospital admission)NT-proBNP blood levels
cardiac troponin (cTnT)Baseline (hospital admission)cardiac troponin blood levels
Non-Invasive Blood Pressure (NIBP)Baseline (hospital admission)Non-invasive blood pressure (NIBP) is measured continuously using a Finapres device. Outcomes are recorded as real-time systolic, diastolic, and mean arterial pressure values.
Baroreflex Sensitivity (BRS)Baseline (hospital admission)Baroreflex Sensitivity (BRS) quantifies the autonomic regulation of blood pressure by measuring the change in heart rate in response to spontaneous fluctuations in blood pressure. It is calculated from continuous blood pressure and ECG recordings (using Finapres). BRS is expressed in ms/mmHg, with higher values indicating stronger baroreflex function.

Secondary

MeasureTime frameDescription
Blood CRP levelBaseline (hospital admission)C-reactive protein (CRP) level in the blood (inflammatory marker)
Blood neutrophil-to-lymphocyte ratio (NLR)Baseline (hospital admission)The neutrophil-to-lymphocyte ratio (NLR), calculated by dividing the neutrophil count by the lymphocyte count, is an inflammatory marker.
Stroke localization in the brainBaseline (hospital admission)Manual segmentation of the acute ischemic lesion will be performed on the MRI of the brain
Fazekas scaleBaseline (hospital admission)The Fazekas scale is a widely used method to visually rate hyperintense white matter signal abnormalities in magnetic resonance imaging (MRI) data. It ranges from 0 (no lesions) to 3.
Global cortical atrophy scaleBaseline (hospital admission)Visual rating of cerebral atrophy on MRI images. Ranges from 0 (no lesions) to 39.
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)Baseline (hospital admission)The 26-item IQCODE questionnaire is completed by an informant to assess changes in cognitive function over the past 10 years in elderly individuals. Each item is rated on a 5-point scale from 1 (much improved) to 5 (much worse). The total score is calculated as the mean of all items, giving a range of 1-5. A mean score of ≥3.44 indicates significant cognitive decline.
Presence for pre-existing fatigue (yes/no)Baseline (hospital admission)Questionnaire (did you experience fatigue before you had your stroke' (yes/no))
Duration of pre-existing fatigueBaseline (hospital admission)Questionnaire ('how long did you experience fatigue' (\< 1 week, \< 3 months, 3-6 months and \> 6 months)
Patient Health Questionnaire-9 (PHQ-9)Baseline (hospital admission)The PHQ-9 is a 9-item questionnaire assessing the frequency of depressive symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), giving a total score range of 0-27. Total scores can be interpreted as follows: 0-4: minimal or no depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression
Montreal Cognitive Assessment (MoCA) questionnaire3 months after baselineQuestionnaire. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.
Montreal Cognitive Assessment (MoCA) score12 months after baselineQuestionnaire.MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.
Insomnia Severity Index (ISI)Baseline (hospital admission)Insomnia will be assessed by using the Insomnia Severity Index (ISI). The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Complete blood count abnormalities: yes/noBaseline (hospital admission)Clinical decision based on the analysis of the blood sample results
Renal insufficiency: yes/noBaseline (hospital admission)Clinical decision based on the analysis of the blood sample results
Electrolyte imbalance: yes/noBaseline (hospital admission)Clinical decision based on the analysis of the blood sample results
Abnormal liver enzymes: yes/noBaseline (hospital admission)Clinical decision based on the analysis of the blood sample results
Dyslipidemia: yes/noBaseline (hospital admission)Clinical decision based on the analysis of the blood sample results
Diabetes: yes/noBaseline (hospital admission)Clinical decision based on the analysis of the blood sample results
Thyroid disorder: yes/noBaseline (hospital admission)Clinical decision based on the analysis of the blood sample results
Iron deficiency: yes/noBaseline (hospital admission)Clinical decision based on the analysis of the blood sample results
Epworth Sleepiness Scale (ESS)Baseline (hospital admission)Description and scoring: the ESS is a questionnaire consisting of 8 daily-life situations in which the patient rates their likelihood of falling asleep on a scale from 0 (would never doze) to 3 (high chance of dozing). Total score = sum of the 8 items → possible range 0 to 24. Common interpretation: 0-10: normal daytime sleepiness 11-24: excessive daytime sleepiness (higher score = greater sleepiness)
Generalized Anxiety Disorder scale (GAD-7)Baseline (hospital admission)Description and scoring: the GAD-7 is a 7-item questionnaire assessing symptoms of generalized anxiety over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day). Total score: sum of all 7 items → possible range 0-21. Common interpretation: 0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety

Countries

Belgium

Contacts

CONTACTAnissa Ourtani, MD
Anissa.OURTANI@chu-brugmann.be3224754819
PRINCIPAL_INVESTIGATORAnissa Ourtani, MD

CHU Brugmann

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026