Registry Study of Cerebral Small Vessel Disease

N/ARecruitingNCT07342075

Dongzhimen Hospital, Beijing50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cerebral Small Vessel Diseases Cognitive Impairment Diffusion Tensor Imaging

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age above 50 years (including 50-year-old); 2. MRI confirmed the presence of typical imaging changes of CSVD; 3. Voluntary participation in the study and be willing to sign the Informed Consent Form. Exclusion Criteria: 1. Patients with acute ischemic stroke or acute intracranial hemorrhage (e.g., epidural hematoma, subdural hematoma, subarachnoid hemorrhage, intracerebral hemorrhage, etc.) or a history of cerebral infarction (non-lacunar) or intracranial hemorrhage within the past 3 months; 2. Significant non-vascular white matter lesions (e.g., multiple sclerosis, adult-onset leukoencephalopathy, metabolic encephalopathy, etc.); 3. Patients with a history of cognitive impairment due to other causes (e.g., normal pressure hydrocephalus, Alzheimer's disease, Parkinson's disease, multiple sclerosis, encephalitis, etc.); 4. Severe hepatic, renal, or cardiac insufficiency (ALT or AST \>2 times the upper limit of normal, or serum creatinine \>1.5 times the upper limit of normal, or New York Heart Association \[NYHA\] functional class III or IV); 5. Patients with psychiatric disorders that affect study medication administration and evaluation; 6. Contraindications to MRI examination (e.g., claustrophobia, presence of an implantable pacemaker, etc.); 7. Patients unable to comply with follow-up examinations or other study procedures due to residential location or other reasons; 8. Participation in other clinical trial projects.

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

Changes in whole-brain fiber connectivity at 6 month

Measure changes in whole-brain fiber connectivity on brain MRI diffusion tensor imaging (DTI).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

Registry Study of Cerebral Small Vessel Disease

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts