Clinical trial NCT04816500: Remote Ischemic Conditioning on Cerebral Small Vessel Disease
Official title: Study of Efficacy and Safety of Remote Ischemic Conditioning on Cerebral Small Vessel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Small Vessel Diseases
Keywords: Cerebral Small Vessel Diseases
Remote Ischemic Conditioning
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes of volume of WMHs
timeFrame: From baseline to 1 year treatment
Secondary outcomes:
measure: Changes in hemodynamic parameters on TCD.
timeFrame: From baseline to 1 year treatment
measure: Changes of cognition evaluation on MoCA.
timeFrame: From baseline to 1 year treatment
Other outcomes:
Locations:
city: Beijin
country: China
facility: Xuanwu hospital;Capital Medical University
Study officials:
References: