Remote Ischemic Conditioning on Cerebral Small Vessel Disease

Cerebral Small Vessel Diseases Clinical Trial

— RIC-SVD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04816500
• Other study ID #: Capital Medical U
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Capital Medical University
• Contact: Yuan Wang, MD
• Phone: +861083199085
• Email: wilma0106[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases

Intervention

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.

Drug:
• Regular treatment
Antiplatelet agents and statins administration, vascular risk factors control.

Locations

Country	Name	City	State
China	Xuanwu hospital;Capital Medical University	Beijin

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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