Remote Ischemic Conditioning for Cognitive Impairment in Cerebral Small Vessel Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorJiangsu Province Nanjing Brain Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Remote ischemic conditioning using IPC-906 device
DeviceA 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
DeviceThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Remote ischemic conditioningExperimental treatment 1 intervention
Group B: Sham remote ischemic conditioningSham comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and 90 days after randomization.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: