Registry Study of Cerebral Small Vessel Disease

ConditionsCerebral Small Vessel Diseases Cognitive Impairment Diffusion Tensor Imaging

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age50+

SponsorDongzhimen Hospital, Beijing

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age above 50 years (including 50-year-old);

MRI confirmed the presence of typical imaging changes of CSVD;

Voluntary participation in the study and be willing to sign the Informed Consent Form.

Disqualifiers

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;

Significant non-vascular white matter lesions (e.g., multiple sclerosis, adult-onset leukoencephalopathy, metabolic encephalopathy, etc.);

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.);

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);

Trial population

The study population mainly consisted of patients from the outpatient and inpatient departments of the Department of Neurology at Dongzhimen Hospital.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants

are grouped into 1 trial group

Group A: Patient Gourp

Trial 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

Other outcomes

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

Time frame

6 months

Numbers in all-cause hospitalization from baseline to 6 month

Numbers in all-cause hospitalization

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dongzhimen Hospital, Beijing

Lead sponsor

Source ClinicalTrials.gov

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