Understanding fatigue after a first ischemic stroke
Better Understanding of Fatigue After STroke
NA · Brugmann University Hospital · NCT06292377
This project will try to see if measures of heart rhythm, blood tests, and brain scans can explain why adults who recently had a first ischemic stroke develop ongoing fatigue.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brugmann University Hospital (other) |
| Locations | 2 sites (Brussels and 1 other locations) |
| Trial ID | NCT06292377 on ClinicalTrials.gov |
What this trial studies
Adults with a first-ever ischemic stroke who are admitted within 72 hours to two Brussels stroke units will be enrolled and undergo ECG (for heart rate variability), transthoracic echocardiography, blood sampling, brain MRI, and standardized questionnaires for fatigue, cognition, mood, and sleep. The study will compare early (<3 months) and late (>3 months) post-stroke fatigue and relate symptom patterns to markers of autonomic dysfunction. Researchers will analyze whether altered heart rate variability and other biological markers correlate with persistent fatigue after stroke. No experimental drug or device is being tested; the focus is on physiological and clinical measurements to clarify underlying mechanisms.
Who should consider this trial
Good fit: Adults (≥18) admitted to CHU Brugmann or UZ Brussel with a first-ever ischemic stroke within 72 hours who can undergo MRI and complete fatigue, cognitive, mood, and sleep assessments in French or Dutch.
Not a fit: People with prior strokes or other structural brain lesions, severe language impairment or dementia, life expectancy under one year, pregnancy, or who cannot speak French or Dutch are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the findings could help identify patients at higher risk of post-stroke fatigue and point to new ways to prevent or treat it.
How similar studies have performed: Previous observational work has linked autonomic dysfunction and altered heart rate variability to worse post-stroke outcomes, but interventions to prevent or treat post-stroke fatigue based on these findings remain unproven, so the approach is exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brussels and 1 other locations
- CHU Brugmann — Brussels, Belgium (RECRUITING)
- UZ Brussel — Brussels, Belgium (RECRUITING)
Study contacts
- Principal investigator: Anissa Ourtani, MD — CHU Brugmann
- Study coordinator: Anissa Ourtani, MD
- Email: Anissa.OURTANI@chu-brugmann.be
- Phone: 3224754819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke