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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Small Vessel Diseases
• Intervention / Treatment: Device: Automatic ischemic conditioning treatment instrument; Drug: Regular treatment

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan Wang, MD; Phone Number: +861083199085; Email: wilma0106@163.com

Study Locations

• China
  • Beijin, China
    • Recruiting
    • Xuanwu hospital;Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Automatic ischemic conditioning treatment instrument; 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.
Other: Regular treatment	Drug: Regular treatment; Antiplatelet agents and statins administration, vascular risk factors control.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Remote Ischemic Conditioning; Cerebral Small Vessel Diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Small Vessel Diseases
• Other Study ID Numbers: Capital Medical U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No