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The incidence of cerebral small vessel disease (CSVD) increases with age, affecting approximately 5% of individuals over 50 years old and nearly all individuals over 90 years old. CSVD is also the most important vascular factor contributing to cognitive decline, with 45% of dementia patients attributed to CSVD. Existing interventions are similar to secondary prevention strategies for cardiovascular and cerebrovascular diseases, and no specific therapies are currently available.
CSVD-related cognitive impairment (CSVDCI) predominantly involves attention, processing speed, and executive functions, with relatively preserved memory function, and may be accompanied by non-cognitive clinical manifestations such as gait disturbances, emotional and behavioral disorders, and bladder dysfunction. Although CSVDCI can be classified under vascular cognitive impairment (VCI), there are certain differences in its clinical manifestations.
In summary, it is necessary to develop more targeted treatments for CSVD. We attempt to establish a "symptom-tongue coating-gut microbiota-imaging" system to provide data support for the subsequent exploration of CSVD treatments based on traditional Chinese medicine (TCM) syndrome differentiation and treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Gourp |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Montreal Cognitive Assessment (MoCA) at 6 month | Change from baseline in Montreal Cognitive Assessment (MoCA). Score range is 0-30. Higher score means good cognition. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Mini-Mental State Examination (MMSE) at 6 month | Change from baseline in Mini-Mental State Examination (MMSE). Score range is 0-30. Higher score means good cognition. | 6 months |
| Changes in whole-brain fiber connectivity at 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers in new vascular events from baseline to 6 month | New vascular events include ischemic stroke, TIA, cerebral hemorrhage, MI, pulmonary embolism, thrombosis, peripheral arterial occlusion | 6 months |
| Numbers in all-cause hospitalization from baseline to 6 month |
Inclusion Criteria:
Exclusion Criteria:
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The study population mainly consisted of patients from the outpatient and inpatient departments of the Department of Neurology at Dongzhimen Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beida Ren, PhD | Contact | +86-18810900836 | 18810900836@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700 | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D059345 | Cerebral Small Vessel Diseases |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Stool specimens from patients will be collected.
Measure changes in whole-brain fiber connectivity on brain MRI diffusion tensor imaging (DTI). |
| 6 months |
| Change from baseline in trail making test (TMT) at 6 month | Change from baseline in trail making test (TMT).TMT contains TMT-A and TMT-B. Both are related to age and education. The longer the duration of both tests, the poorer the ability to concentrate, process and perform. | 6 months |
| Change from baseline in Tinetti Performance Oriented Mobility Assessment (POMA) at 6 month | Change from baseline in Tinetti Performance Oriented Mobility Assessment (POMA). Score range is 0-28. Lower score means higher risk of falling. | 6 months |
| Change from baseline in instrumental activities of daily living (IADL) at 6 month | Change from baseline in instrumental activities of daily living (IADL). Score range is 0-24. Higher score means better daily living. | 6 months |
| Change from baseline in Modified Rankin Scale (mRS) at 6 month | Change from baseline in Modified Rankin Scale (mRS).Score range is 0-6. Higher score means greater disability. | 6 months |
| Change from baseline in the symptom at 6 month | Change from baseline in the symptom. The study plans to analyze whether there are statistically significant differences in the incidence of major symptoms before and after treatment. Patient-reported outcomes (PROs) will be used to record the degree of change in patients' symptoms from baseline (expressed as a percentage, with >100% indicating symptom worsening and <100% indicating symptom relief). Meanwhile, baseline and 6-month tongue coating photos will be preserved. | 6 months |
| Change from baseline in gut microbiota at 6 month | Change from baseline in gut microbiota. Metagenomic sequencing technology will be applied to the analysis. | 6 months |
Numbers in all-cause hospitalization |
| 6 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |