An interventional study of Remote ischemic conditioning using IPC-906 device and Sham remote ischemic conditioning using IPC-906 device in Cerebral Small Vessel Disease and Cognitive Impairment, sponsored by Jiangsu Province Nanjing Brain Hospital. Not yet recruiting at 1 site in China. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Jiangsu Province Nanjing Brain Hospital · Not applicable, Interventional, and Treatment
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.
Cerebral small vessel disease (CSVD) is a leading cause of vascular cognitive impairment, characterized by white matter hyperintensities, lacunes, and microbleeds on MRI. Current treatment options for CSVD-related cognitive impairment are limited, and there is a critical need for safe, noninvasive interventions that can improve cognitive function and delay disease progression.
Remote ischemic conditioning (RIC) is a noninvasive, low-cost procedure induced by intermittent cuff inflation on a limb to produce brief episodes of ischemia and reperfusion. Experimental and clinical studies suggest that RIC can improve cerebral perfusion, protect the neurovascular unit, and modulate inflammatory and endothelial pathways, making it a promising strategy for CSVD.
In this single-center, randomized, double-blind, sham-controlled trial, we will enroll 40 patients with CSVD-related mild cognitive impairment. Participants will be randomized to receive either RIC (cuff inflation to 200 mmHg for 5 minutes followed by 5 minutes of reperfusion, 5 cycles per session) or sham RIC (cuff inflation to 60 mmHg, 5 cycles per session). The intervention will be administered twice daily for 90 days, in addition to standard medical therapy.
Cognitive function will be assessed by the Montreal Cognitive Assessment (MoCA). MRI will be used to quantify white matter hyperintensities and diffusion tensor imaging parameters, and EEG will be used to evaluate functional connectivity. Activities of daily living and safety outcomes will also be recorded. This study will provide clinical and mechanistic evidence on whether RIC can prevent or ameliorate cognitive impairment in patients with CSVD.
121 studies on the registry are indexed under Cerebral Small Vessel Diseases; 66 are open to participants now.
This study's planned enrollment of 40 is below the median of 84 across 69 interventional studies indexed under Cerebral Small Vessel Diseases.
Browse Cerebral Small Vessel Diseases studies →Jiangsu Province Nanjing Brain Hospital is the lead sponsor of 22 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Remote ischemic conditioning plus standard medical therapy.
Device: Remote ischemic conditioning using IPC-906 device
Sham remote ischemic conditioning plus standard medical therapy
Device: Sham remote ischemic conditioning using IPC-906 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.
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.
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.
Time frame: Baseline and 90 days after randomization.
Change in total white matter hyperintensity (WMH) volume on brain MRI (milliliters).
Total WMH volume (mL) will be quantified on 3D T2-FLAIR brain MRI using semi-automated volumetric segmentation and normalized to intracranial volume. The outcome is the change in total WMH volume from baseline to 90 days between the two groups.
Time frame: Baseline and 90 days.
Change in mean diffusivity (MD) of cerebral white matter on diffusion tensor MRI (×10-³ mm²/s).
Mean diffusivity (×10-³ mm²/s) will be calculated from diffusion tensor imaging in predefined cerebral white matter regions of interest. The outcome is the change in MD from baseline to 90 days between the two groups.
Time frame: Baseline and 90 days.
Change in fractional anisotropy (FA) of cerebral white matter on diffusion tensor MRI.
Fractional anisotropy values in predefined cerebral white matter regions will be derived from diffusion tensor imaging. The outcome is the change in FA from baseline to 90 days between the two groups.
Time frame: Baseline and 90 days.
Change in axial diffusivity (AD) of cerebral white matter on diffusion tensor MRI (×10-³ mm²/s).
Axial diffusivity (×10-³ mm²/s) in predefined cerebral white matter regions will be obtained from diffusion tensor imaging. The outcome is the change in AD from baseline to 90 days between the two groups.
Time frame: Baseline and 90 days.
Change in radial diffusivity (RD) of cerebral white matter on diffusion tensor MRI (×10-³ mm²/s).
Radial diffusivity (×10-³ mm²/s) in predefined cerebral white matter regions will be obtained from diffusion tensor imaging. The outcome is the change in RD from baseline to 90 days between the two groups.
Time frame: Baseline and 90 days.
Change in EEG global functional connectivity (graph-theoretical global efficiency index).
Weighted functional connectivity matrices will be constructed from resting-state EEG signals, and graph-theoretical global efficiency (dimensionless) will be calculated as a summary index of whole-brain functional connectivity. The outcome is the change in global efficiency from baseline to 90 days between the two groups.
Time frame: Baseline and 90 days.
Change in Activities of Daily Living (ADL) scale score.
The Activities of Daily Living Scale (ADL) is a \[\[X-item\]\] questionnaire assessing basic daily self-care abilities. Each item is scored from \[\[A\]\] to \[\[B\]\] points, yielding a total score ranging from \[\[0\]\] to \[\[100\]\] points. Higher scores indicate worse activities of daily living (greater functional impairment). The outcome is the change in ADL total score from baseline to 90 days between the two groups.
Time frame: Baseline and 90 days.
Incidence of adverse events related to remote ischemic conditioning.
Including skin petechiae, bruising, limb discomfort or numbness, and any serious adverse events.
Time frame: Baseline to 90 days.
Plan to share: No — There is no current plan to share individual participant data (IPD) from this trial with external researchers. De-identified, aggregate study results will be reported in publications and presentations in accordance with institutional and national regulations.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cerebral Small Vessel Diseases→
Jiangsu Province Nanjing Brain Hospital