Cerebral Small Vessel Disease Progression by Stroke Type
Official title: Biomarker-based Assessment of Cerebral Small Vessel Disease Progression After Lacunar and Territorial Stroke - a Prospective Cohort Study
Run by University Hospital Ulm · NCT07611136 · Data updated 2026-11-12
This study tests whether CSVD progresses differently if a patient has a concurrent ischemic stroke, using MRI and blood biomarkers in adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | University Hospital Ulm Academic / other |
| Locations | 1 site (Ulm, Baden-Wurttemberg) |
| Status | Recruiting |
| Started | March 26, 2026 |
| Main results expected | April 1, 2028 |
| Study ends | April 1, 2028 |
| Registry record updated | May 28, 2026 |
| Trial ID | NCT07611136 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with MRI-confirmed CSVD (white matter hyperintensities Fazekas 1–3) and the ability to provide informed consent in German.
✕Probably not a fit
Individuals without CSVD progression patterns or those lacking active stroke features may see limited direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational study aiming to understand how cerebral small vessel disease (CSVD) evolves over time in relation to the type of ischemic stroke. Researchers will categorize participants based on MRI findings into CSVD without stroke, CSVD with lacunar stroke, or CSVD with territorial stroke and will measure blood biomarkers that may reflect CSVD course. Outcomes include neuropsychological and neurological function, quality of life, and stroke recurrence risk, with MRI to track CSVD changes. The study is conducted at University Hospital Ulm in Germany and focuses on adults with MRI-confirmed CSVD.
Why it matters
Potential benefit: If successful, findings could improve understanding of CSVD progression and help tailor monitoring and preventive strategies based on stroke type and biomarker patterns.
How similar studies have gone: Previous research has explored CSVD biomarkers and imaging, but this specific progression-by-stroke-type approach is relatively new and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Evidence of cerebral small vessel disease on brain MRI, defined as white matter hyperintensities (Fazekas grade 1-3) * Assignment to one of the following study groups based on MRI findings: * cerebral small vessel disease without evidence of an acute ischemic stroke * cerebral small vessel disease with acute lacunar ischemic stroke * cerebral small vessel disease with acute territorial ischemic stroke * Ability to provide written informed consent * Sufficient German language skills to understand study procedures and assessments Exclusion Criteria: * Alternative plausible causes of white matter hyperintensities other than cerebral small vessel disease (e.g. inflammatory central nervous system disorders, leukodystrophies, brain tumors) * Known neurodegenerative diseases (e.g. Parkinson's disease, Alzheimer's disease, other dementias) * Acute or recent traumatic brain injury * Contraindications to magnetic resonance imaging * Pregnancy or breastfeeding * Life expectancy of less than one year * Inability to comply with study procedures or follow-up visits
Where it's running
-
University Hospital Ulm, Department of Neurology, Germany
Ulm, Baden-Wurttemberg, Germany Recruiting
Study contacts
- Study coordinator: Mona E Laible, MD
- Email: mona.laible@uniklinik-ulm.de
- Phone: +49(0)7311770
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Brain activity and thinking problems in cerebral small vessel disease
This project will see if EEG brain signals and home-based cognitive training or tACS can detect and improve thinking problems in older adults with cerebral small vessel disease.
-
Deep phenotyping to explore recovery in young adults after stroke
This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.
-
Stem cell therapy for chronic stroke recovery
This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.
-
AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals
This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.
-
Web-based therapy using action observation and mirror therapy for arm weakness after stroke
This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.
-
Remote Ischaemic Conditioning for Fatigue After Stroke 2
Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.