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RecruitingNCT07889531RICUpdated Oct 22, 2026

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

An interventional study of remote ischemic conditioning (RIC) and Control in Moya Moya Disease and Moyamoya Syndrome, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Prevention

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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). 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.

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.

02

Conditions studied

  • Moya Moya Disease
  • Moyamoya Syndrome

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03

In context

Moyamoya Disease

61 studies on the registry are indexed under Moyamoya Disease; 26 are open to participants now.

This study's planned enrollment of 256 is above the median of 60 across 31 interventional studies indexed under Moyamoya Disease.

Browse Moyamoya Disease studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 481 studies on the registry; 287 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The patient is aged between 18 and 70 years old;
  2. There is evidence from MRA, CTA or DSA, and the patient is professionally diagnosed with moyamoya disease or moyamoya syndrome;
  3. 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);
  4. 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;
  5. The patient has signed the informed consent form.

Exclusion criteria

Exclusion Criteria:

  1. 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.);
  2. 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;
  3. 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;
  4. 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;
  5. Uncontrolled severe hypertension, that is, seated systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg after drug treatment;
  6. Severe hemostatic disorder or severe coagulation dysfunction;
  7. Contraindications to RIC treatment:

(1) 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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
256 participants (estimated)

Study arms

  • Active comparator
    intervention

    Device: remote ischemic conditioning (RIC)

  • Sham comparator
    control

    Device: Control

Interventions

  • Deviceremote ischemic conditioning (RIC)

    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.

  • DeviceControl

    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

06

What researchers measure

Primary outcomes

  1. Ischemic cerebrovascular events within 180 days after intervention

    Time frame: one month; three months; six months

07

Study locations

1 of 1 sites recruiting
  • Titan Hospital; Capital Medical University
    Beijing, Beijing Municipality, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07889531
Responsible party
Wang Shuo (PhD, Beijing Tiantan Hospital) — Principal investigator
First posted
Oct 22, 2026
Start date
Oct 10, 2026
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 22, 2026

Study contacts

Liu Qingyuan
Contact
13260457220@163.com
+86 13260457220

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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