Cerebral Small Vessel Disease
Conditions
Brief summary
The goal of this observational study is to learn about neuroimage and biomarkers in the cerebral small vessel disease. The main questions it aims to answer are: * How does neurovascular coupling change during the progression of CSVD? * How is the pattern/mapping of alterations in CSVD biomarkers? Participants will be observed and visit the research center annually to perform multi-modal MRI, PET, neuropsychological tests, and blood tests.
Detailed description
This observational study recruits participants with cerebral small vessel disease (CSVD) from hospitals and community-based populations. Healthy volunteers will also be recruited as controls. Longitudinal follow-up of these participants will help clarify the significance of neuroimaging and biological biomarkers during the development and progression of CSVD. The investigators aim to establish a longitudinal cohort covering the spectrum of CSVD and identify key biomarkers associated with disease progression and cognitive decline. All participants will undergo multimodal MRI, PET imaging (optional) with different tracers, and blood biomarker assessments. Using multimodal MRI, the investigators will investigate alterations in neurovascular coupling and their role in the pathophysiology of CSVD. In addition, PET imaging (optional) and blood biomarkers will be used to characterize the spatial and temporal patterns of disease-related biomarker changes. Furthermore, additional neuroimaging and digital biomarkers will be evaluated within the cohort to improve disease characterization and prognostic prediction.
Interventions
None listed
Sponsors
Ruijin Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥18 years. 2. Evidence of cerebral small vessel disease (CSVD) on brain MRI, meeting at least one of the following imaging criteria: * White matter hyperintensities (WMH) with a total Fazekas score ≥2; * Fazekas score =1 with at least two vascular risk factors (hypertension, hyperlipidemia, diabetes mellitus, obesity, current smoking, or a history of vascular events other than stroke); * Fazekas score =1 accompanied by the presence of lacunes; * Imaging evidence of a recent subcortical lacunar infarction. 3. Independent in activities of daily living (modified Rankin Scale \[mRS\] ≤2). 4. Able and willing to provide written informed consent.
Exclusion criteria
1. Acute ischemic stroke with a diffusion-weighted imaging (DWI) lesion \>20 mm in diameter. 2. Acute intracerebral hemorrhage. 3. Acute subarachnoid hemorrhage, a history of aneurysmal subarachnoid hemorrhage or cerebrovascular malformation, or the presence of an untreated intracranial aneurysm \>3 mm in diameter. 4. Previously diagnosed neurodegenerative disorders, such as Alzheimer's disease (AD) or Parkinson's disease (PD). 5. Definite non-vascular white matter diseases, including multiple sclerosis, adult-onset leukodystrophy, metabolic encephalopathy, or other non-vascular white matter disorders. 6. Major psychiatric disorders diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 7. Contraindications to MRI (e.g., severe claustrophobia or MRI-incompatible implants). 8. Severe systemic diseases (e.g., active malignancy) with an expected life expectancy of less than 5 years. 9. Inability to complete scheduled follow-up because of geographic, logistical, or other reasons. 10. Concurrent participation in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global cognitive ability | baseline, 1 year, 2-year, 3-year, 5-year,10-year | Mini-mental state examination |
| Executive function | baseline, 1 year, 2-year, 3-year, 5-year,10-year | Clock drawing test |
| Visual memory | baseline, 1 year, 2-year, 3-year, 5-year,10-year | Rey-Osterich complex figure test |
| Short-term memory | baseline, 1 year, 2-year, 3-year, 5-year,10-year | Auditory verbal learning test |
| Executive memory | baseline, 1 year, 2-year, 3-year, 5-year,10-year | Symbol-digit test |
| Spatial executive function | baseline, 1 year, 2-year, 3-year, 5-year,10-year | Trail making test |
| Naming ability | baseline, 1 year, 2-year, 3-year, 5-year,10-year | Boston naming test |
| Language ability | baseline, 1 year, 2-year, 3-year, 5-year,10-year | Language fluency test |
| Sleep quality | baseline, 1 year, 2-year, 3-year, 5-year,10-year | Sleep disorder |
| Movement ability | baseline, 1 year, 2-year, 3-year, 5-year,10-year | Part III of the Unified Parkinson's Disease Rating Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brain volume | baseline, 1 year, 2-year, 3-year, 5-year,10-year | Annual changes of volumes of brain |
| Connectivity integrity of the neural circuit | baseline, 1 year, 2-year, 3-year, 5-year,10-year | Annual changes of hippocampus related neural connectivity |
| Volume of white matter lesions | baseline, 1 year, 2-year, 3-year, 5-year,10-year | Structural and functional MRI measures, including arterial spin labeling (ASL), diffusion MRI (dMRI), susceptibility-weighted imaging (SWI) and fluid-attenuated inversion recovery (FLAIR). |
Countries
China
Outcome results
None listed