Remote Ischemic Conditioning on Cerebral Small Vessel Disease

NCT04816500 | Unknown

• 1 other identifier: Capital Medical U
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Small Vessel Diseases

Keywords

Cerebral Small Vessel Diseases; Remote Ischemic Conditioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in hemodynamic parameters on TCD.

  From baseline to 1 year treatment

• Changes of cognition evaluation on MoCA.

  From baseline to 1 year treatment

Study Arms (2)

RIC group

EXPERIMENTAL

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

Regular treatment

OTHER

Drug: Regular treatment

Interventions

Automatic ischemic conditioning treatment instrument DEVICE

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.

RIC group

Regular treatment DRUG

Antiplatelet agents and statins administration, vascular risk factors control.

Regular treatment

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Xuanwu hospital;Capital Medical University

Beijin, China

RECRUITING

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yuan Wang, MD

CONTACT

+861083199085; wilma0106@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study of Efficacy and Safety of remote ischemic conditioning on cerebral small vessel disease

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: January 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: March 25, 2021

Record last verified: 2021-03

Locations

CN (1)