Cerebral small vessel disease
Conditions
Interventions
Case group:No intervention (in CSVD patients)
Control Group:Non-intervention (Non-CSVD patients but with vascular risk factors)
Sponsors
Hunan Provincial Hospital of Integrated Traditional and Western Medicine (Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine)
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: This study sets inclusion criteria and group definition standards. (1) Common Inclusion Criteria 1. Age 45 to 80 years, with no restriction on gender. 2. The participant or their legal representative has signed the informed consent form. 3. Clear consciousness, with normal language comprehension and expression, and vision and hearing sufficient to meet the requirements of scale assessments and gait tests. 4. Able to cooperate in completing brain MRI, neuropsychological scale assessments, and single-task/dual-task gait tests. 5. Allowance for continuation of previous baseline treatments, but related treatments should be stable before enrollment, i.e., the same drug and route of administration should be maintained for =6 weeks, with cumulative dose changes 7 days. (2) Case Group Definition Criteria for CSVD In addition to meeting the common inclusion criteria, participants must also satisfy the following conditions: The diagnostic criteria for CSVD refer to the "Chinese Expert Consensus on the Diagnosis and Treatment of CSVD 2021" by the Chinese Society of Research Hospitals, the "Chinese Guidelines for the Diagnosis and Treatment of CSVD 2020" by the Neurology Branch of the Chinese Medical Association and its Vascular Disease Study Group, and the "Standards for Reporting Vascular Changes on Neuroimaging 2 (STRIVE-2)" (2023). If a participant has any of the established CSVD imaging markers defined in the aforementioned consensus/guidelines (e.g., recent subcortical small infarcts, lacunes, WMH, CMB, EPVS, or brain atrophy [when present alone, other diseases should be excluded]), combined with age/risk factors and clinical syndromes, they can be classified as having imaging-indicated CSVD and included in the study. (3) Control Group Definition Criteria for Non-CSVD Participants with Vascular Risk Factors In addition to meeting the common inclusion criteria, participants must also satisfy the following conditions: 1. At least one vascular risk factor, such as hypertension, diabetes, dyslipidemia, smoking history, or alcohol consumption history. 2. Brain MRI does not meet the diagnostic criteria for CSVD imaging, and no clear CSVD imaging markers reach the diagnostic threshold. 3. Recruited from outpatient or inpatient populations, serving as a control group for elderly gait parameters.
Exclusion criteria
Exclusion criteria: 1. Large-scale cerebral infarction occurred within the past 3 months, or there is a recent acute cerebrovascular event. 2. There is a clear stroke mechanism related to major artery stenosis, such as stenosis of =50% in the extracranial or intracranial major arteries on the lesion side, or having undergone carotid endarterectomy or stent placement within the past 6 months, or having definite evidence of cardioembolic stroke. 3. Non-vascular causes of leukoencephalopathy, such as demyelinating diseases, carbon monoxide poisoning, or hereditary leukodystrophy. 4. Coexisting dementia, Parkinson's disease, Parkinson syndrome, or other neurological diseases that independently cause gait abnormalities. 5. Severe mental disorders, or inability to cooperate with assessments due to drug or alcohol dependence. 6. Severe impairment of heart, liver, or kidney function, active malignancy, or other severe systemic diseases deemed unsuitable for enrollment by the investigator. 7.Presence of bone, joint, spinal, peripheral nerve, or muscle diseases significantly affecting gait, such as severe cervical and lumbar spondylosis, severe arthritis, recent joint injury, or severe osteoporosis with deformity or pain. 8. Contraindications for MRI, such as implanted metallic devices or claustrophobia. 9. Use of medications that significantly affect gait or cognition within 48–72 hours prior to testing. 10. Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imaging indicators (Deep medullary venous sign score);Dual-task gait cost (walking speed); | — |
Secondary
| Measure | Time frame |
|---|---|
| Lifestyle habits and past medical history (including general information, risk factors, smoking history, and alcohol consumption history, etc.);Imaging biomarkers (white matter hyperintensities);Imaging indicators (lacunar);Imaging indicators (cerebral microbleeds);Imaging indicators (perivascular space enlargement);Imaging indicators (cerebral atrophy);Imaging Total Burden Score (Wardlaw Score);Blood cell analysis;Liver function;Renal function;Lipid Profile (Four Items);Coagulation function;D-dimer;Von Willebrand factor (vWF);Von Willebrand factor-cleaving protease (ADAMTS13);Transforming Growth Factor-beta 1 (TGF-ß1);Mini-Mental State Examination Scale (MMSE Scale);Montreal Cognitive Assessment Scale (MoCA Scale);Gait Assessment Indices (Other Key Spatiotemporal Parameters Under Dual-Task Conditions);Matrix Metalloproteinase-9 (MMP-9);Neurofilament light chain protein (NfL);Glial Fibrillary Acidic Protein (GFAP);Single-task gait parameter (walking speed);Single-task gait parameters (gait variability, step height, step length, stance phase, swing phase, and other parameters); | — |
Countries
China
Contacts
Public ContactGe Jiwen / Fang Rui
Hunan Provincial Hospital of Integrated Traditional and Western Medicine (Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine)
Outcome results
None listed