StrokeSHIELDNCT07503301
Small Vessel Disease and Cerebral Infarct Healing InErvation Via Limb Distant Adaptation
A study testing Medical-grade ischemic preconditioning training instrument and Standard Treatment in people with Stroke and Small Vessel Cerebrovascular Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Cerebral infarction (ischemic stroke) and cerebral small vessel disease (CSVD) represent major global causes of disability, cognitive decline, and mortality. Despite advances in reperfusion therapies, many patients experience residual neurological deficits and remain at high risk for recurrent stroke and vascular… Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Stroke, Small Vessel Cerebrovascular Disease
- What is being tested?
- Medical-grade ischemic preconditioning training instrument and Standard Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Mar 2029
- Phase
- Interventional
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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 50 and 65 years.
- Definite diagnosis of cerebral infarction or cerebral small vessel disease-related cerebral infarction confirmed by brain MRI or other imaging examinations.
- Ability to complete the 3-month follow-up and RIC intervention (for the experimental group).
- Few underlying comorbidities, limited to hypertension and hyperlipidemia; clear consciousness with the ability to provide informed consent.
- Modified Rankin Scale (mRS) score < 2, with no severe cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA).
- Enrolled within 48 hours after the onset of stroke symptoms (i.e., from the time the patient was last known to be well, during the acute phase).
Who cannot join
- Complicated with diabetes mellitus, smoking history, or other metabolic disorders.
- Complicated with other types of stroke (e.g., cardioembolic stroke, large artery atherosclerotic stroke, etc.).
- Presence of severe cognitive impairment, depression, or other psychiatric or neurological disorders.
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
2ndAffiliated Hospital, School of Medicine, Zhejiang Universit, Hangzhou, Zhejiang 310000
Hangzhou, Zhejiang, 310000
About this study
Official title: the Role and Mechanism of Distant Ischemic Adaptation in Improving Cognitive Impairment in Cerebral Infarction and Cerebral Small Vessel Disease
Cerebral infarction (ischemic stroke) and cerebral small vessel disease (CSVD) represent major global causes of disability, cognitive decline, and mortality. Despite advances in reperfusion therapies, many patients experience residual neurological deficits and remain at high risk for recurrent stroke and vascular dementia. Effective adjunctive treatments that are safe, accessible, and capable of improving long-term outcomes are urgently needed.
Distant ischemic adaptation (also known as remote ischemic conditioning, RIC) is a non-invasive, safe, and cost-effective intervention that induces endogenous protection against ischemic injury by applying brief, intermittent ischemia to a remote limb. While several large-scale clinical trials (e.g., RICAMIS, RECAST) have demonstrated promising neuroprotective effects of RIC in acute ischemic stroke, results remain inconsistent across studies, particularly in patients with CSVD. Key challenges include the lack of standardized RIC protocols and the absence of specific biomarkers to predict treatment response and elucidate underlying mechanisms.
To address these gaps, this study aims to identify potential effector proteins and specific biomarkers that mediate the therapeutic effects of RIC in patients with cerebral infarction and CSVD. By collecting and analyzing serum samples from RIC-treated patients and controls, we seek to uncover molecular mechanisms underlying RIC-induced neuroprotection and cognitive preservation. The findings may establish a theoretical foundation for optimizing RIC therapy, provide novel drug targets, and ultimately improve clinical outcomes for patients suffering from ischemic stroke and small vessel disease.
- Conditions
- Stroke, Small Vessel Cerebrovascular Disease
- Being tested
- Medical-grade ischemic preconditioning training instrument, Standard Treatment
- Keywords
- stroke
- Medical subject headings
- Stroke, Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical-grade ischemic preconditioning training instrumentDevice
The remote ischemic conditioning (RIC) intervention consists of two sessions per day, with 5 cycles per session (each cycle comprising 5 minutes of inflation followed by 5 minutes of deflation), performed alternately on both upper arms. The inflation pressure is set at baseline systolic blood pressure + 20 mmHg, gradually increased up to a maximum of 200 mmHg. If the patient experiences discomfort, the pressure may be appropriately reduced to allow adaptation, then gradually increased again. At least 3 complete cycles must be completed per session, and an overall compliance rate of ≥80% is considered as achieving the target. Concurrently, patients will receive standard medical treatment (antihypertensive therapy, lipid-lowering therapy, and single antiplatelet therapy). The total intervention duration is 3 months.
For enrolled patients with cerebral infarction, management will be conducted by the neurosurgery department. During hospitalization, the RIC procedure will be administered an
Standard TreatmentOther
Standard Treatment
| Study group | Role | What they receive |
|---|---|---|
| Stroke Control Group | Sham comparator | standard treatment against stroke Receives: Other: Standard Treatment |
| Stroke RIC Group | Experimental | standard treatment against stroke + RIC intervention Receives: Device: Medical-grade ischemic preconditioning training instrument |
| CSVD Control Group | Sham comparator | standard treatment against CSVD Receives: Other: Standard Treatment |
| CSVD RIC Group | Experimental | standard treatment against CSVD + RIC intervention Receives: Device: Medical-grade ischemic preconditioning training instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in White Matter Hyperintensity (WMH) Volume on Brain MRI
Brain MRI will be performed to assess changes in white matter hyperintensity volume, including lesion extent and DWI signal characteristics. The primary outcome is the change in WMH volume from baseline to 3 months.
Measured: Baseline, Month 3
Change in National Institutes of Health Stroke Scale (NIHSS) Score
The NIHSS is a 15-item neurological examination scale used to assess stroke severity. Scores range from 0 to 42, with higher scores indicating more severe neurological deficits. The primary outcome is the change in NIHSS score from baseline to 3 months.
Measured: Baseline, Month 1, Month 3
Change in Cognitive Function (MoCA and MMSE Scores)
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Examination (MMSE). The MoCA scores range from 0 to 30, with higher scores indicating better cognitive function. The MMSE scores range from 0 to 30, with higher scores indicating better cognitive status. The primary outcome is the change in both scores from baseline to 3 months.
Measured: Baseline, Month 1, Month 3
Secondary outcomes (3)
Serum Levels of Inflammatory and Neuroprotective Biomarkers
Serum samples will be collected to assess dynamic changes in inflammatory cytokines (e.g., TNF-α, IL-1β, IL-6) and neuroprotective factors. Changes in biomarker levels will be compared between baseline and follow-up time points.
Measured: Baseline, Month 1, Month 3
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety will be assessed by monitoring the frequency, severity, and relatedness of adverse events and serious adverse events, including allergic reactions, changes in liver and renal function, and coagulation parameters.
Measured: Throughout the 3-month intervention period
Compliance Rate with RIC Intervention
Adherence to the RIC intervention will be evaluated. Compliance is defined as completing ≥80% of the prescribed RIC sessions (two sessions per day, 5 cycles per session, over 3 months).
Measured: Throughout the 3-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Feb 2026
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503301
- Sponsor's protocol ID
- 2026-0150
- Acronym
- SHIELD
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided