Cerebral Small Vessel DiseaseRIC-CSVDNCT07317557
Remote Ischemic Conditioning for Cognitive Impairment in Cerebral Small Vessel Disease
A study testing Remote ischemic conditioning using IPC-906 device in people with Cerebral Small Vessel Disease and Cognitive Impairment, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Cerebral Small Vessel Disease, Cognitive Impairment
- What is being tested?
- Remote ischemic conditioning using IPC-906 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing Brain Hospital
Nanjing, Jiangsu
Xiaoyin Wang, MD, +86 18810650523, cherryhfkaku2011@163.com
About this study
Official title: Mechanisms of Remote Ischemic Conditioning in Preventing and Treating Cognitive Impairment in Cerebral Small Vessel Disease
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.
Read the detailed description
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.
- Being tested
- Remote ischemic conditioning using IPC-906 device, Sham remote ischemic conditioning using IPC-906 device
- Keywords
- cerebral small vessel disease; cognitive impairment; remote ischemic conditioning; white matter hyperintensities; EEG functional connectivity
- Medical subject headings
- Cerebral Small Vessel Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioning using IPC-906 deviceDevice
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 deviceDevice
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 group | Role | What they receive |
|---|---|---|
| Remote ischemic conditioning | Experimental | Remote ischemic conditioning plus standard medical therapy. Receives: Device: Remote ischemic conditioning using IPC-906 device |
| Sham remote ischemic conditioning | Sham comparator | Sham remote ischemic conditioning plus standard medical therapy Receives: Device: Sham remote ischemic conditioning using IPC-906 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 90 days after randomization.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoyin Wang, MD, Principal investigator, Department of Neurology, Nanjing Brain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317557
- Sponsor's protocol ID
- 2025-KY142-01
- Other IDs
- 82402970
- Acronym
- RIC-CSVD
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Remote Ischemic Conditioning in Preventing and Treating Cognitive Impairment in Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT07317557
- Acronym / sponsor ID
- RIC-CSVD / 2025-KY142-01
- Keywords
- cerebral small vessel disease; cognitive impairment; remote ischemic conditioning; white matter hyperintensities; EEG functional connectivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jiangsu Province Nanjing Brain HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic conditioning | Experimental | Device: Remote ischemic conditioning using IPC-906 deviceRemote ischemic conditioning plus standard medical therapy. |
| Sham remote ischemic conditioning | Sham comparator | Device: Sham remote ischemic conditioning using IPC-906 deviceSham remote ischemic conditioning plus standard medical therapy |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioning using IPC-906 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. | Device | Remote ischemic conditioning |
| Sham remote ischemic conditioning using IPC-906 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. | Device | Sham remote ischemic conditioning |
Primary outcome
Change in Montreal Cognitive Assessment (MoCA) score from baseline to 90 days.
Time frame: Baseline and 90 days after randomization.
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.
8 secondary outcomes
Change in total white matter hyperintensity (WMH) volume on brain MRI (milliliters).
Time frame: Baseline and 90 days.
Change in mean diffusivity (MD) of cerebral white matter on diffusion tensor MRI (×10-³ mm²/s).
Time frame: Baseline and 90 days.
Change in fractional anisotropy (FA) of cerebral white matter on diffusion tensor MRI.
Time frame: Baseline and 90 days.
Change in axial diffusivity (AD) of cerebral white matter on diffusion tensor MRI (×10-³ mm²/s).
Time frame: Baseline and 90 days.
Change in radial diffusivity (RD) of cerebral white matter on diffusion tensor MRI (×10-³ mm²/s).
Time frame: Baseline and 90 days.
Change in EEG global functional connectivity (graph-theoretical global efficiency index).
Time frame: Baseline and 90 days.
Change in Activities of Daily Living (ADL) scale score.
Time frame: Baseline and 90 days.
Incidence of adverse events related to remote ischemic conditioning.
Time frame: Baseline to 90 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoyin Wang, MD principal investigator
Department of Neurology, Nanjing Brain Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning using IPC-906 device in people with Cerebral Small Vessel Disease and Cognitive Impairment, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyin wang, MD (+86 18810650523, cherryhfkaku2011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montreal Cognitive Assessment (MoCA) score from baseline to 90 days. (time frame: Baseline and 90 days after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.