Remote Ischemic Conditioning on Cerebral Small Vessel Disease

Study Overview
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Brief Summary
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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.

Official Title
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Study of Efficacy and Safety of Remote Ischemic Conditioning on Cerebral Small Vessel Disease

Conditions
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Cerebral Small Vessel Diseases

Intervention / Treatment
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* Device: Automatic ischemic conditioning treatment instrument
* Drug: Regular treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 45-80 years old, and gender not limited; patient and/or caregiver report of cognitive declines with regard to memory and/or other cognitive domains lasting for at least 3 months; 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; the presence of lacunes and/or WMHs and/or CMBs on MRI 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: clinical manifestations indicating that the patient was at the end-stage of cSVD; hereditary or inflammatory small vessel disorders cerebral venous injury or changes; diagnosis of nervous system degenerative diseases Alzheimer's disease, DLB, frontotemporal dementia (FTD), and so on; history of intracranial hemorrhage or significant bleeding in other parts of the body brain tumor, psychoses, or acute stroke within 6 months; cardiogenic embolism; significant bleeding coagulation dysfunction; serious liver and kidney function is not complete, malignant tumor, or serious diseases need to medical intervention or surgery; any soft tissue or vascular injury, and any disease of the extremities that may contraindicate RIC; pregnant women; life expectancy<6 months; refused to sign a consent form, poor compliance, or not to cooperate to complete whole treatment, and so on.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIC group<br>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. | Device: Automatic ischemic conditioning treatment instrument<br>* 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.<br>|
| Other: Regular treatment<br> | Drug: Regular treatment<br>* Antiplatelet agents and statins administration, vascular risk factors control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of volume of WMHs | The volume of WMHs was measured on Flairs and DTI. By calculating the mean diffusivity (MD) and FA of water diffusion, DTI can assess the integrity and connectivity of WM tissue from a network perspective, and reconstruct the distribution of WM pathways in the brain three-dimensionally. | From baseline to 1 year treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hemodynamic parameters on TCD. | The peak systolic, mean, and end diastolic blood flow velocities (BFV) at the most proximal segment of bilateral MCAs, BA were measured by TCD | From baseline to 1 year treatment | 
| Changes of cognition evaluation on MoCA. | The Beijing version of MoCA were used to evaluate to evaluate the cognitive functions of patients, referring to the degree of an individual's capacity with respect to orientation, memory, calculation, language, execution and visuospatial function and so on | From baseline to 1 year treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Small Vessel Diseases, Remote Ischemic Conditioning