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Moya Moya DiseaseRICNCT07889531

A Multicenter, Prospective, Double-blind, Randomized Controlled Study on the Efficacy and Safety of Ischemic Preconditioning Therapy Versus Optimal Medical Therapy in Reducing the Recurrence of Ischemic Events in Symptomatic Moyamoya Disease

A study testing remote ischemic conditioning (RIC) in people with Moya Moya Disease and Moyamoya Syndrome, run by Beijing Tiantan Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This clinical trial aims to investigate whether remote ischemic conditioning (RIC) can reduce the risk of cerebral ischemic events, delay clinical progression, and improve long-term outcomes in patients with symptomatic Moyamoya disease (Moyamoya syndrome). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Moya Moya Disease, Moyamoya Syndrome
What is being tested?
remote ischemic conditioning (RIC)
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
256 participants
Where
1 siteChina
Study dates
10 Oct 2026to 31 Dec 2027
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient is aged between 18 and 70 years old;
  • There is evidence from MRA, CTA or DSA, and the patient is professionally diagnosed with moyamoya disease or moyamoya syndrome;
  • The patient has ischemic symptoms related to moyamoya vasculopathy, including transient ischemic attack (TIA) and cerebral infarction (limb weakness, hemiplegia, paresthesia, speech disorder, etc. The symptoms may recur in the unilateral limb, or progress to bilateral attacks or alternating bilateral attacks);
  • After clinical evaluation, non-surgical treatment strategies such as drug therapy and risk factor management are planned to be adopted currently, and the patient is not planned to undergo cerebral blood flow revascularization within 6 months after randomization during screening;
  • The patient has signed the informed consent form.

Who cannot join

  • History of intracranial hemorrhage (such as subarachnoid hemorrhage, cerebral parenchymal hemorrhage and intraventricular hemorrhage) and other cerebrovascular diseases (such as intracranial aneurysm, cerebral arteriovenous malformation, arteriovenous fistula, etc.);
  • History of brain tumor, severe craniocerebral trauma, encephalitis, meningitis and other central nervous system inflammatory diseases, or other major craniocerebral diseases, any form of invasive brain treatment history and radiotherapy history;
  • Presence of severe or uncontrolled systemic diseases, or vital organ dysfunction that the investigator judges may significantly increase the subject's research risk or affect the completion of follow-up, including but not limited to severe cardiac insufficiency (ejection fraction <50% or NYHA class III-IV cardiac function), severe liver function abnormality (such as ALT or AST > 2 times the upper limit of normal value), severe renal insufficiency (such as serum creatinine > 3 mg/dL), severe or uncontrolled respiratory diseases, severe non-cardiovascular comorbidities with expected survival time <1 year;
  • There is a clear source of cardiogenic embolism, including rheumatic mitral or aortic valve stenosis, prosthetic valve, atrial fibrillation, atrial flutter, sick sinus syndrome, left atrial myxoma, patent foramen ovale, left ventricular mural thrombus, valve vegetation, congestive heart failure, bacterial endocarditis, or other cardiovascular diseases that affect study participation;
  • Uncontrolled severe hypertension, that is, seated systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg after drug treatment;
  • Severe hemostatic disorder or severe coagulation dysfunction;
  • Contraindications to RIC treatment:
  • Combined with upper extremity peripheral vascular disease or those judged by the investigator to be unsuitable for upper arm cuff compression, especially vascular lesions that may increase the risk of upper extremity ischemia, including known moderate to severe stenosis or occlusion of the subclavian artery, axillary artery, brachial artery, radial artery or ulnar artery, subclavian steal syndrome, and obvious symptoms of upper extremity ischemia; (2) There are local upper extremity conditions that may affect the safe implementation of RIC, including severe skin or soft tissue infection, skin breakage, unhealed wounds, recent upper extremity trauma or fracture, obvious hematoma, severe edema or lymphedema, arteriovenous fistula or hemodialysis access, PICC or other vascular access not suitable for compression, recent upper extremity deep vein thrombosis or thrombophlebitis, etc.; (3) Known history of allergy to RIC equipment or its constituent materials 8. Patients who refuse follow-up or cannot communicate due to severe mental illness; 9. Unfit for taVNS wearing due to skin breakage, infection, redness and swelling at the wearing site; 10. Pregnant and lying-in women; 11. Participate in other studies at the same period.

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, 1 recruiting
  • Titan Hospital; Capital Medical University

    Beijing, Beijing Municipality

    Recruiting

Other trials in China

About this study

Official title: A Study on the Efficacy and Safety of Remote Ischemic Conditioning Therapy Versus Optimal Medical Therapy in Reducing the Recurrence of Ischemic Events in Symptomatic Moyamoya Disease

This clinical trial aims to investigate whether remote ischemic conditioning (RIC) can reduce the risk of cerebral ischemic events, delay clinical progression, and improve long-term outcomes in patients with symptomatic Moyamoya disease (Moyamoya syndrome). The primary research questions include:

Does RIC lower the incidence of cerebral ischemic events (e.g., stroke, transient ischemic attack) compared to standard care? Does RIC slow disease progression, as measured by neuroimaging markers (e.g., cerebral blood flow, collateral vessel development) and clinical assessments? Does RIC improve long-term functional outcomes (e.g., modified Rankin Scale, quality of life) in this patient population? Study Design This is a multicenter, prospective, double-blind, randomized controlled trial (RCT). Eligible participants who provide informed consent and complete baseline evaluations will be dynamically randomized (1:1) via a central randomization system using the minimization method to either the intervention group or the control group.

Read more

Intervention Group: Patients will receive RIC therapy (using an automated device) in addition to optimal medical treatment (OMT). RIC will be administered twice daily for 6 months, with each session consisting of 5 cycles of bilateral upper-limb cuff inflation (5 min at a preset high pressure) followed by deflation (5 min), totaling ~45 min per session. OMT includes antiplatelet agents, antihypertensives, antidiabetics, and lipid-lowering drugs as clinically indicated.

Control Group: Patients will receive a sham RIC procedure (using the same device but with cuffs inflated to a fixed low pressure of 60 mmHg) alongside identical OMT. The frequency, duration, and cycling protocol will match those of the intervention group.

Being tested
remote ischemic conditioning (RIC), Control
Medical subject headings
Moyamoya Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • remote ischemic conditioning (RIC)Device

    Intervention Group: Patients will receive RIC therapy (using an automated device) in addition to optimal medical treatment (OMT). RIC will be administered twice daily for 6 months, with each session consisting of 5 cycles of bilateral upper-limb cuff inflation (5 min at a preset high pressure) followed by deflation (5 min), totaling ~45 min per session. OMT includes antiplatelet agents, antihypertensives, antidiabetics, and lipid-lowering drugs as clinically indicated.

  • ControlDevice

    Control Group: Patients will receive a sham RIC procedure (using the same device but with cuffs inflated to a fixed low pressure of 60 mmHg) alongside identical OMT. The frequency, duration, and cycling protocol will match those of the intervention group

Study groups in NCT07889531
Study groupRoleWhat they receive
interventionActive comparatorNot described
Receives: Device: remote ischemic conditioning (RIC)
controlSham comparatorNot described
Receives: Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ischemic cerebrovascular events within 180 days after intervention

    Measured: one month; three months; six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2026
  2. Study start10 Oct 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
256 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07889531
Sponsor's protocol ID
HX-A-2026080
Acronym
RIC
Status last verified
Oct 2026
First submitted
16 Oct 2026
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing remote ischemic conditioning (RIC) in people with Moya Moya Disease and Moyamoya Syndrome, run by Beijing Tiantan 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 22 Oct 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 Liu Qingyuan (+86 13260457220, 13260457220@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ischemic cerebrovascular events within 180 days after intervention (time frame: one month; three months; six months). 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 22 Oct 2026.

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