Moyamoya DiseaseNCT06041659
Functional Magnetic Resonance-Based Observations of Brain Networks in Moyamoya Disease Patients Under Anesthesia
An observational study of Moyamoya Disease, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Moyamoya disease is characterized by progressive stenosis of the genesis of the distal internal carotid arteries bilaterally and progressive generation of compensatory pathological vascular networks at the basis cranii, and these pathological vasculature has poor vascular reactivity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moyamoya Disease
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2023to 31 Dec 2025
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We plan to recruit consecutive patients with moyamoya disease who are to undergo direct or indirect revascularization surgery from August 2023 to December 2025 at Beijing Tiantan Hospital of Capital Medical University.
Who may be able to join
- Patients with moyamoya disease scheduled for direct or indirect intracranial and extracranial revascularization surgery
- Age between 18-65 years
- Obtain written informed consent.
Who cannot join
- Patients with preoperative claustrophobia, sensory or motor aphasia that are unable to understand and cooperate with the examination
- Preoperative cranial imaging suggesting cerebral infarction lesion diameter >15mm
- Patients allergic to anesthetic drugs
- Metal implants in the body
- Undergoing other experimental drug or instrumentation trials
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
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Shu Li, M.D., 13699223065, lishu@bjtth.org
About this study
Official title: Functional Magnetic Resonance-Based Observations of Brain Networks and Cerebrovascular Reactivity in Patients With Moyamoya Disease Under Anesthetic Sedation, A Prospective Observational Cohort Study
Moyamoya disease is characterized by progressive stenosis of the genesis of the distal internal carotid arteries bilaterally and progressive generation of compensatory pathological vascular networks at the basis cranii, and these pathological vasculature has poor vascular reactivity. Perioperative circulatory management of patients with smoky vessels to ensure perfusion of brain tissue and integrity of brain network during surgery to minimize postoperative impairment of neurological functions, including motor, sensory, emotional and cognitive functions, is the key point of perioperative circulatory management of moyamoya disease. Functional Magnetic Resonance Imaging (fMRI) has been routinely used in various cerebrovascular diseases to further evaluate cerebrovascular reserve and cerebral network connectivity. The purpose of this study is to observe the changes in cerebral blood flow, cerebral oxygen metabolism, cerebral oxygen metabolism rate, and cerebral network connectivity in adult patients with moyamoya disease in cerebral ischemia-sensitive areas under anesthesia to provide a basis for exploring anesthesia management to improve cognitive function and cerebral network connectivity in these patients.
- Conditions
- Moyamoya Disease
- Keywords
- Moyamoya Disease, Cerebral Network, Cognitive Function, Anesthesia
- Medical subject headings
- Moyamoya Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of brain functional network
Measured: Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min
Secondary outcomes (2)
Postoperative delirium
Measured: Day1-5 after surgery
Electroencephalogram changes
Measured: Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start24 Oct 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
- Investigators
- Shu Li, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041659
- Sponsor's protocol ID
- 2023022
- Status last verified
- Feb 2025
- First submitted
- 11 Sep 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance-Based Observations of Brain Networks and Cerebrovascular Reactivity in Patients With Moyamoya Disease Under Anesthetic Sedation, A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06041659
- Acronym / sponsor ID
- 2023022
- Conditions
- Moyamoya Disease
- Keywords
- Moyamoya Disease, Cerebral Network, Cognitive Function, Anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Sep 2023 (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.
Moyamoya disease is characterized by progressive stenosis of the genesis of the distal internal carotid arteries bilaterally and progressive generation of compensatory pathological vascular networks at the basis cranii, and these pathological vasculature has poor vascular reactivity. Perioperative circulatory management of patients with smoky vessels to ensure perfusion of brain tissue and integrity of brain network during surgery to minimize postoperative impairment of neurological functions, including motor, sensory, emotional and cognitive functions, is the key point of perioperative circulatory management of moyamoya disease. Functional Magnetic Resonance Imaging (fMRI) has been routinely used in various cerebrovascular diseases to further evaluate cerebrovascular reserve and cerebral network connectivity. The purpose of this study is to observe the changes in cerebral blood flow, cerebral oxygen metabolism, cerebral oxygen metabolism rate, and cerebral network connectivity in adult patients with moyamoya disease in cerebral ischemia-sensitive areas under anesthesia to provide a basis for exploring anesthesia management to improve cognitive function and cerebral network connectivity in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to recruit consecutive patients with moyamoya disease who are to undergo direct or indirect revascularization surgery from August 2023 to December 2025 at Beijing Tiantan Hospital of Capital Medical University.
Key inclusion criteria (3 listed)
- Patients with moyamoya disease scheduled for direct or indirect intracranial and extracranial revascularization surgery
- Age between 18-65 years
- Obtain written informed consent.
Key exclusion criteria (5 listed)
- Patients with preoperative claustrophobia, sensory or motor aphasia that are unable to understand and cooperate with the examination
- Preoperative cranial imaging suggesting cerebral infarction lesion diameter >15mm
- Patients allergic to anesthetic drugs
- Metal implants in the body
- Undergoing other experimental drug or instrumentation trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of brain functional network
Time frame: Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min
2 secondary outcomes
Postoperative delirium
Time frame: Day1-5 after surgery
Electroencephalogram changes
Time frame: Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min
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 13 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Shu Li principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moyamoya Disease, 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 3 inclusion and 5 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 13 Feb 2025. 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. 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 Shu Li (8613699223065, lishu@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of brain functional network (time frame: Before sedation, after sedation and after maintenan the blood pressure at baseline 100%-120% for 15min). 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 13 Feb 2025.