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临床试验/NCT06832839
NCT06832839招募中不适用

Study on the Mechanism of Cognitive Impairment in Patients with Moyamoya Disease

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2024年12月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
360
试验地点
1
主要终点
Change in composite score of neurocognitive function at 6 months after treatment.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Change in composite score of neurocognitive function at 6 months after treatment.

时间窗: 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.

次要结局

  • Changes in composite score of neurocognitive function at 12 and 24 months after treatment.(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.(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.(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.(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.(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.(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.(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.(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.(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.(6, 12 and 24 months during follow-up)
  • Changes in Degree Centrality assessed by multimodal MRI at 6, 12, and 24 months after treatment.(6, 12 and 24 months during follow-up)
  • Changes in Clustering Coefficient assessed by multimodal MRI at 6, 12, and 24 months after treatment.(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.(6, 12 and 24 months during follow-up)
  • Changes in Network Density assessed by multimodal MRI at 6, 12, and 24 months after treatment.(6, 12 and 24 months during follow-up)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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