Remote Ischemic Conditioning for Cognitive Impairment in Cerebral Small Vessel Disease

Sponsor
Jiangsu Province Nanjing Brain Hospital
Study ID
NCT07317557
Status
Not Yet Recruiting

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Conditions

  • Cerebral Small Vessel Disease
  • Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
30 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jan 5, 2026
Start date
Apr 1, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Remote ischemic conditioning
    Remote ischemic conditioning plus standard medical therapy.
  • Sham Comparator: Sham remote ischemic conditioning
    Sham remote ischemic conditioning plus standard medical therapy

Primary Outcome Measure

Change in Montreal Cognitive Assessment (MoCA) score from baseline to 90 days. [ Time Frame: Baseline and 90 days after randomization. ]

Central Contacts

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