Remote Ischemic Conditioning for Cognitive Impairment in Cerebral Small Vessel Disease

NCT07317557 | Not Yet Recruiting

• 2 other identifiers: 2025-KY142-0182402970
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, sham-controlled trial aims to evaluate the effect of remote ischemic conditioning (RIC) on cognitive function in patients with cerebral small vessel disease-related mild cognitive impairment. Forty eligible participants will be randomized 1:1 to receive either RIC or sham RIC twice daily for 90 days in addition to standard medical therapy. The primary outcome is the change in Montreal Cognitive Assessment (MoCA) score from baseline to 90 days. Secondary outcomes include changes in white matter hyperintensity burden and diffusion tensor imaging metrics on MRI, EEG functional connectivity, and activities of daily living.

Conditions

Cerebral Small Vessel Disease; Cognitive Impairment

Keywords

cerebral small vessel disease; cognitive impairment; remote ischemic conditioning; white matter hyperintensities; EEG functional connectivity

Outcome Measures

Primary Outcomes (1)

• Change in Montreal Cognitive Assessment (MoCA) score from baseline to 90 days.

  The primary endpoint is the difference in mean MoCA score change from baseline to 90 days between the remote ischemic conditioning group and the sham group.

  Baseline and 90 days after randomization.

Secondary Outcomes (8)

• Change in total white matter hyperintensity (WMH) volume on brain MRI (milliliters).

  Baseline and 90 days.

• Change in mean diffusivity (MD) of cerebral white matter on diffusion tensor MRI (×10-³ mm²/s).

  Baseline and 90 days.

• Change in fractional anisotropy (FA) of cerebral white matter on diffusion tensor MRI.

  Baseline and 90 days.

• Change in axial diffusivity (AD) of cerebral white matter on diffusion tensor MRI (×10-³ mm²/s).

  Baseline and 90 days.

• Change in radial diffusivity (RD) of cerebral white matter on diffusion tensor MRI (×10-³ mm²/s).

  Baseline and 90 days.

Study Arms (2)

Remote ischemic conditioning

EXPERIMENTAL

Remote ischemic conditioning plus standard medical therapy.

Device: Remote ischemic conditioning using IPC-906 device

Sham remote ischemic conditioning

SHAM COMPARATOR

Sham remote ischemic conditioning plus standard medical therapy

Device: Sham remote ischemic conditioning using IPC-906 device

Interventions

Remote ischemic conditioning using IPC-906 device DEVICE

A pneumatic cuff is placed on one upper limb and inflated to 200 mmHg for 5 minutes followed by 5 minutes of reperfusion, repeated for 5 cycles (total 45 minutes) per session, twice daily for 90 days, in addition to standard medical therapy.

Remote ischemic conditioning

Sham remote ischemic conditioning using IPC-906 device DEVICE

The same cuff procedure is applied, but cuff pressure is set at 60 mmHg, which does not induce ischemia. The schedule is identical: 5 minutes inflation and 5 minutes reperfusion, 5 cycles (45 minutes) per session, twice daily for 90 days, in addition to standard medical therapy.

Sham remote ischemic conditioning

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-80 years.
• Diagnosis of cerebral small vessel disease according to the Chinese Guidelines for the Diagnosis and Treatment of Cerebral Small Vessel Disease (2020).
• Mild cognitive impairment with a Montreal Cognitive Assessment (MoCA) score of 18-25.
• The patient or a legally authorized representative is able and willing to sign written informed consent.

You may not qualify if:

• Any condition that is unsuitable for remote ischemic conditioning, including soft tissue injury, limb deformity or vascular injury in the upper limb, bleeding disorders, or systolic blood pressure \> 200 mmHg.
• History or presence of neurological or psychiatric disorders that may interfere with participation or outcome assessment, such as other cerebrovascular diseases, Parkinson's disease, or major depressive disorder.
• Current or past severe systemic diseases deemed inappropriate for the study by the investigator, including but not limited to severe cardiovascular diseases (e.g., congestive heart failure, severe arrhythmia, myocardial infarction), severe hepatic diseases (e.g., cirrhosis), severe renal diseases (e.g., requiring hemodialysis or peritoneal dialysis), hematologic diseases with bleeding tendency (e.g., hemophilia), poorly controlled diabetes (blood glucose \> 16.8 mmol/L or \< 2.8 mmol/L) or with severe complications, active or uncontrolled systemic autoimmune diseases or primary/secondary immunodeficiency, or malignancy.
• Laboratory abnormalities, including absolute neutrophil count \< 1.5 × 10⁹/L, platelet count \< 100 × 10⁹/L, hemoglobin \< 90 g/L, AST or ALT \> 2.5 × upper limit of normal (ULN), total bilirubin \> 1.5 × ULN, or serum creatinine \> 1.5 × ULN.
• Coagulation abnormalities, including for patients not on anticoagulant/antithrombotic therapy: INR \> 1.7 or APTT \> 1.25 × ULN; and for patients on anticoagulant/antithrombotic therapy: INR \> 3.0 or APTT \> 1.5 × ULN.
• Positive tests for hepatitis B with detectable HBV-DNA, or positive serology for hepatitis C, syphilis (TPAb/RPR), or HIV.
• Pregnant or breastfeeding women.
• Contraindications to MRI (e.g., pacemaker or other metallic implants, severe claustrophobia).
• Participation in another clinical trial within 3 months prior to enrollment.
• Severe trauma or major surgery within 3 months before remote ischemic conditioning, or planned surgery during the study period (except minor procedures and laparoscopic procedures performed within 4 weeks before baseline).
• History of substance abuse or alcoholism within 1 year prior to enrollment.
• Any other condition that may increase risk or interfere with the interpretation of study results, as judged by the investigator.

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead

Study Sites (1)

Nanjing Brain Hospital

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Xiaoyin Wang, MD

  Department of Neurology, Nanjing Brain Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyin wang, MD

CONTACT

+86 18810650523; cherryhfkaku2011@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)