Study of Efficacy and Safety of Remote Ischemic Conditioning on Cerebral Small Vessel Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes of volume of WMHs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
RIC group
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.
干预措施: Automatic ischemic conditioning treatment instrument (Device)
Regular treatment
干预措施: Regular treatment (Drug)
结局指标
主要结局
Changes of volume of WMHs
时间窗: From baseline to 1 year treatment
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.
次要结局
- Changes in hemodynamic parameters on TCD.(From baseline to 1 year treatment)
- Changes of cognition evaluation on MoCA.(From baseline to 1 year treatment)
研究者
Ji Xunming,MD,PhD
Study of Efficacy and Safety of remote ischemic conditioning on cerebral small vessel disease
Capital Medical University