Remote Ischemic Conditioning on Cerebral Small Vessel Disease (RIC-SVD)

Capital Medical University

Status: Unknown

Conditions: Cerebral Small Vessel Diseases

Treatments: Device: Automatic ischemic conditioning treatment instrument; Drug: Regular treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04816500

Capital Medical U

Details and patient eligibility

About

This trial is a randomized, controlled, single-center, double-blind trial. Cerebral small vessel disease (CSVD) patients will be recruited and randomized into RIC or control group.The protective effect of remote ischemic conditioning (RIC) on CSVD will be investigated.

Enrollment: 60 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 45-80 years old, and gender not limited;
2. patient and/or caregiver report of cognitive declines with regard to memory and/or other cognitive domains lasting for at least 3 months;
3. neither normal nor demented on the basis of the criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) with normal or slightly impaired activities of daily living9, with Mini-mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above)10 and Montreal Cognitive Assessment (MoCA) score ≤ 26;
4. the presence of lacunes and/or WMHs and/or CMBs on MRI
5. absence of vascular narrowing >50% luminal diameter that could cause hemodynamic changes (MFV>90 cm/s for the intracranial internal carotid artery, 100 cm/s for MCA, >80 cm/s for basilar artery [BA] or vertebral artery) measured by TCD

Exclusion criteria

1. clinical manifestations indicating that the patient was at the end-stage of cSVD;
2. hereditary or inflammatory small vessel disorders
3. cerebral venous injury or changes;
4. diagnosis of nervous system degenerative diseases Alzheimer's disease, DLB, frontotemporal dementia (FTD), and so on;
5. history of intracranial hemorrhage or significant bleeding in other parts of the body
6. brain tumor, psychoses, or acute stroke within 6 months;
7. cardiogenic embolism;
8. significant bleeding coagulation dysfunction;
9. serious liver and kidney function is not complete, malignant tumor, or serious diseases need to medical intervention or surgery;
10. any soft tissue or vascular injury, and any disease of the extremities that may contraindicate RIC;
11. pregnant women;
12. life expectancy<6 months;
13. refused to sign a consent form, poor compliance, or not to cooperate to complete whole treatment, and so on.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

RIC group

Experimental group

Description:

Device: Remote ischemic conditioning RIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed twice daily for consecutive 1 year after enrollment.

Treatment:

Device: Automatic ischemic conditioning treatment instrument

Regular treatment

Other group

Treatment:

Drug: Regular treatment