Clinical trial NCT06832839: Study on the Mechanism of Cognitive Impairment in Patients with Moyamoya Disease
Official title: Study on the Mechanism of Cognitive Impairment in Patients with Moyamoya Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moyamoya Disease
Keywords: Cognitive Impairment
Moyamoya Disease
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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, 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in composite score of neurocognitive function at 6 months after treatment.
timeFrame: 6 months during follow-up
Secondary outcomes:
measure: Changes in composite score of neurocognitive function at 12 and 24 months after treatment.
timeFrame: 12 and 24 months during follow-up
measure: Rate of participants experiencing cerebrovascular events (TIA, infarction and hemorrhage) within 6, 12 and 24 months after treatment.
timeFrame: 6, 12 and 24 months during follow-up
measure: Changes in neurological function assessed by modified Rankin scale (mRS) at 6, 12, and 24 months following treatment.
timeFrame: 6, 12 and 24 months during follow-up
measure: Changes in neurological function assessed by National Institute of Health stroke scale (NIHSS) at 6, 12, and 24 months following treatment.
timeFrame: 6, 12 and 24 months during follow-up
measure: Changes in cerebral blood perfusion assessed by arterial spin labeling (ASL) at 6, 12, and 24 months after treatment.
timeFrame: 6, 12 and 24 months during follow-up
measure: Hemodynamic changes at the terminal segment of internal carotid artery assessed by computational fluid dynamics (CFD) at 6, 12, and 24 months after treatment.
timeFrame: 6, 12 and 24 months during follow-up
measure: 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.
timeFrame: 6, 12 and 24 months during follow-up
measure: Changes in Power Spectral Density (PSD) assessed by electroencephalography (EEG) at 6, 12, and 24 months after treatment will be measured.
timeFrame: 6, 12 and 24 months during follow-up
measure: Changes in Phase Locking Value (PLV) assessed by electroencephalogram (EEG) at 6, 12, and 24 months after treatment will be measured.
timeFrame: 6, 12 and 24 months during follow-up
measure: Changes in Phase-Lag Index (PLI) assessed by electroencephalogram (EEG) at 6, 12, and 24 months after treatment will be measured.
timeFrame: 6, 12 and 24 months during follow-up
measure: Changes in Degree Centrality assessed by multimodal MRI at 6, 12, and 24 months after treatment.
timeFrame: 6, 12 and 24 months during follow-up
measure: Changes in Clustering Coefficient assessed by multimodal MRI at 6, 12, and 24 months after treatment.
timeFrame: 6, 12 and 24 months during follow-up
measure: Changes in Structural Connectivity Strength assessed by multimodal MRI at 6, 12, and 24 months after treatment.
timeFrame: 6, 12 and 24 months during follow-up
measure: Changes in Network Density assessed by multimodal MRI at 6, 12, and 24 months after treatment.
timeFrame: 6, 12 and 24 months during follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
References: