Moyamoya DiseaseNCT06832839
Study on the Mechanism of Cognitive Impairment in Patients with Moyamoya Disease
An observational study of Moyamoya Disease, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The purpose of this study is to comprehensively evaluate the risk factors for cognitive decline in patients with moyamoya disease, identify imaging target areas associated with cognitive damage in the brain, and explore the changes in brain structure and functional networks resulting from cerebral revascularization… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- Revascularization
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2024to 31 Dec 2027
- How long will I take part?
- 24 Months
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Consecutive patients diagnosed with MMD in Beijing Tiantan Hospital will be recruited. Eligibility will be determined through a checklist of inclusion and exclusion criteria.
Who may be able to join
- The admission cerebral angiography (DSA) examination fulfills the diagnostic criteria for moyamoya disease.
- Please sign the informed consent form.
- Participants must be between 18 and 60 years of age.
Who cannot join
- Patients with concurrent atherosclerosis, autoimmune diseases, meningitis, brain tumors, Down syndrome, craniocerebral trauma, prior radioactive head irradiation, or hyperthyroidism, which may result in secondary cerebrovascular lesions leading to symptoms associated with smoke syndrome.
- Individuals younger than 18 years or older than 60 years.
- Those with contraindications for magnetic resonance imaging.
- Patients who are unable to complete cognitive brain assessments
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
Beijing, China, 100070
Qian Zhang, MD, 8613120012579, zhangqianchina@yahoo.com
About this study
The purpose of this study is to comprehensively evaluate the risk factors for cognitive decline in patients with moyamoya disease, identify imaging target areas associated with cognitive damage in the brain, and explore the changes in brain structure and functional networks resulting from cerebral revascularization, as well as their relationship with cognitive improvement.
Read the detailed description
Moyamoya disease (MMD) is a chronic occlusive-stenosis cerebrovascular disease that characterized by the stenosis of internal carotid artery termination and the formation of net-like vessel. It is a multifactorial disease caused by genetic, inflammatory, immunological and other environmental factors. The specific pathogenesis of MMD is still unclear. The treatment modalities of revascularization and conservative management have been used in patients with MMD. Due to the long-term low perfusion state of brain tissue, most patients with MMD experience varying degrees of cognitive dysfunction, although the underlying mechanisms remain unclear. We will employ a combination of 256-lead high-density electroencephalography, multimodal magnetic resonance imaging, and biological samples to conduct a comprehensive evaluation of the risk factors associated with cognitive decline in patients with MMD. Our objectives include identifying target imaging areas indicative of cognitive damage in the brain and exploring the structural and functional changes in the cerebral network resulting from revascularization, as well as their relationship with cognitive improvement.
- Conditions
- Moyamoya Disease
- Being tested
- Revascularization
- Keywords
- Cognitive Impairment, Moyamoya Disease
- Medical subject headings
- Moyamoya Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevascularizationProcedure or surgery
Revascularization
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in composite score of neurocognitive function at 6 months after treatment.
The composite score of neurocognitive function, including Weschsler Adult Intelligence Scale-4th Edition (WAIS-IV), MATRICS Consensus Cognitive Battery (MCCB), Montreal Cognitive Assessment (MoCA), Auditory Verbal Learning Test (AVLT), Rey-Osterrieth complex figure (ROCF), Trail Making Test (TMT), Stroop test, Verbal Fluency Test (VFT), and Boston Naming Test (BNT) will be collected before and 6 months after treatment.
Measured: 6 months during follow-up
Secondary outcomes (14)
Changes in composite score of neurocognitive function at 12 and 24 months after treatment.
The composite score of neurocognitive function, including Weschsler Adult Intelligence Scale-4th Edition (WAIS-IV), MATRICS Consensus Cognitive Battery (MCCB), Montreal Cognitive Assessment (MoCA), Auditory Verbal Learning Test (AVLT), Rey-Osterrieth complex figure (ROCF), Trail Making Test (TMT), Stroop test, Verbal Fluency Test (VFT), and Boston Naming Test (BNT) will be collected before and 12 and 24 months after treatment.
Measured: 12 and 24 months during follow-up
Rate of participants experiencing cerebrovascular events (TIA, infarction and hemorrhage) within 6, 12 and 24 months after treatment.
Measured: 6, 12 and 24 months during follow-up
Changes in neurological function assessed by modified Rankin scale (mRS) at 6, 12, and 24 months following treatment.
Measured: 6, 12 and 24 months during follow-up
Changes in neurological function assessed by National Institute of Health stroke scale (NIHSS) at 6, 12, and 24 months following treatment.
Measured: 6, 12 and 24 months during follow-up
Changes in cerebral blood perfusion assessed by arterial spin labeling (ASL) at 6, 12, and 24 months after treatment.
Measured: 6, 12 and 24 months during follow-up
Hemodynamic changes at the terminal segment of internal carotid artery assessed by computational fluid dynamics (CFD) at 6, 12, and 24 months after treatment.
Measured: 6, 12 and 24 months during follow-up
Morphological changes at the terminal segment of internal carotid artery and middle cerebral artery wall assessed by high-resolution vessel wall imaging at 6, 12, and 24 months after treatment.
Measured: 6, 12 and 24 months during follow-up
Changes in Power Spectral Density (PSD) assessed by electroencephalography (EEG) at 6, 12, and 24 months after treatment will be measured.
Measured: 6, 12 and 24 months during follow-up
Changes in Phase Locking Value (PLV) assessed by electroencephalogram (EEG) at 6, 12, and 24 months after treatment will be measured.
Measured: 6, 12 and 24 months during follow-up
Changes in Phase-Lag Index (PLI) assessed by electroencephalogram (EEG) at 6, 12, and 24 months after treatment will be measured.
Measured: 6, 12 and 24 months during follow-up
Changes in Degree Centrality assessed by multimodal MRI at 6, 12, and 24 months after treatment.
Measured: 6, 12 and 24 months during follow-up
Changes in Clustering Coefficient assessed by multimodal MRI at 6, 12, and 24 months after treatment.
Measured: 6, 12 and 24 months during follow-up
Changes in Structural Connectivity Strength assessed by multimodal MRI at 6, 12, and 24 months after treatment.
Measured: 6, 12 and 24 months during follow-up
Changes in Network Density assessed by multimodal MRI at 6, 12, and 24 months after treatment.
Measured: 6, 12 and 24 months during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start16 Dec 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (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
- 360 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832839
- Sponsor's protocol ID
- KY2024-112-02
- Status last verified
- Jan 2025
- First submitted
- 26 Jan 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Mechanism of Cognitive Impairment in Patients with Moyamoya Disease
- ClinicalTrials.gov ID
- NCT06832839
- Acronym / sponsor ID
- KY2024-112-02
- Conditions
- Moyamoya Disease
- Keywords
- Cognitive Impairment, Moyamoya Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Feb 2025 (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.
The purpose of this study is to comprehensively evaluate the risk factors for cognitive decline in patients with moyamoya disease, identify imaging target areas associated with cognitive damage in the brain, and explore the changes in brain structure and functional networks resulting from cerebral revascularization, as well as their relationship with cognitive improvement.
Detailed description
Moyamoya disease (MMD) is a chronic occlusive-stenosis cerebrovascular disease that characterized by the stenosis of internal carotid artery termination and the formation of net-like vessel. It is a multifactorial disease caused by genetic, inflammatory, immunological and other environmental factors. The specific pathogenesis of MMD is still unclear. The treatment modalities of revascularization and conservative management have been used in patients with MMD. Due to the long-term low perfusion state of brain tissue, most patients with MMD experience varying degrees of cognitive dysfunction, although the underlying mechanisms remain unclear. We will employ a combination of 256-lead high-density electroencephalography, multimodal magnetic resonance imaging, and biological samples to conduct a comprehensive evaluation of the risk factors associated with cognitive decline in patients with MMD. Our objectives include identifying target imaging areas indicative of cognitive damage in the brain and exploring the structural and functional changes in the cerebral network resulting from revascularization, as well as their relationship with cognitive improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Consecutive patients diagnosed with MMD in Beijing Tiantan Hospital will be recruited. Eligibility will be determined through a checklist of inclusion and exclusion criteria.
Key inclusion criteria (3 listed)
- The admission cerebral angiography (DSA) examination fulfills the diagnostic criteria for moyamoya disease.
- Please sign the informed consent form.
- Participants must be between 18 and 60 years of age.
Key exclusion criteria (4 listed)
- Patients with concurrent atherosclerosis, autoimmune diseases, meningitis, brain tumors, Down syndrome, craniocerebral trauma, prior radioactive head irradiation, or hyperthyroidism, which may result in secondary cerebrovascular lesions leading to symptoms associated with smoke syndrome.
- Individuals younger than 18 years or older than 60 years.
- Those with contraindications for magnetic resonance imaging.
- Patients who are unable to complete cognitive brain assessments
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 |
|---|---|---|
| RevascularizationRevascularization | Procedure or surgery | – |
Primary outcome
Change in composite score of neurocognitive function at 6 months after treatment.
Time frame: 6 months during follow-up
The composite score of neurocognitive function, including Weschsler Adult Intelligence Scale-4th Edition (WAIS-IV), MATRICS Consensus Cognitive Battery (MCCB), Montreal Cognitive Assessment (MoCA), Auditory Verbal Learning Test (AVLT), Rey-Osterrieth complex figure (ROCF), Trail Making Test (TMT), Stroop test, Verbal Fluency Test (VFT), and Boston Naming Test (BNT) will be collected before and 6 months after treatment.
14 secondary outcomes
Changes in composite score of neurocognitive function at 12 and 24 months after treatment.
Time frame: 12 and 24 months during follow-up
Rate of participants experiencing cerebrovascular events (TIA, infarction and hemorrhage) within 6, 12 and 24 months after treatment.
Time frame: 6, 12 and 24 months during follow-up
Changes in neurological function assessed by modified Rankin scale (mRS) at 6, 12, and 24 months following treatment.
Time frame: 6, 12 and 24 months during follow-up
Changes in neurological function assessed by National Institute of Health stroke scale (NIHSS) at 6, 12, and 24 months following treatment.
Time frame: 6, 12 and 24 months during follow-up
Changes in cerebral blood perfusion assessed by arterial spin labeling (ASL) at 6, 12, and 24 months after treatment.
Time frame: 6, 12 and 24 months during follow-up
Hemodynamic changes at the terminal segment of internal carotid artery assessed by computational fluid dynamics (CFD) at 6, 12, and 24 months after treatment.
Time frame: 6, 12 and 24 months during follow-up
Morphological changes at the terminal segment of internal carotid artery and middle cerebral artery wall assessed by high-resolution vessel wall imaging at 6, 12, and 24 months after treatment.
Time frame: 6, 12 and 24 months during follow-up
Changes in Power Spectral Density (PSD) assessed by electroencephalography (EEG) at 6, 12, and 24 months after treatment will be measured.
Time frame: 6, 12 and 24 months during follow-up
Changes in Phase Locking Value (PLV) assessed by electroencephalogram (EEG) at 6, 12, and 24 months after treatment will be measured.
Time frame: 6, 12 and 24 months during follow-up
Changes in Phase-Lag Index (PLI) assessed by electroencephalogram (EEG) at 6, 12, and 24 months after treatment will be measured.
Time frame: 6, 12 and 24 months during follow-up
Changes in Degree Centrality assessed by multimodal MRI at 6, 12, and 24 months after treatment.
Time frame: 6, 12 and 24 months during follow-up
Changes in Clustering Coefficient assessed by multimodal MRI at 6, 12, and 24 months after treatment.
Time frame: 6, 12 and 24 months during follow-up
Changes in Structural Connectivity Strength assessed by multimodal MRI at 6, 12, and 24 months after treatment.
Time frame: 6, 12 and 24 months during follow-up
Changes in Network Density assessed by multimodal MRI at 6, 12, and 24 months after treatment.
Time frame: 6, 12 and 24 months during follow-up
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 18 Feb 2025.
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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.
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 4 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 18 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 Qian Zhang, MD (8613120012579, zhangqianchina@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in composite score of neurocognitive function at 6 months after treatment. (time frame: 6 months during follow-up). 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 18 Feb 2025.