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Recruiting NCT06832839

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

Observational Moyamoya Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Revascularization.
Who it may be relevant to
Registry conditions: Moyamoya Disease. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Revascularization
    Revascularization

Primary outcome measures

  • Change in composite score of neurocognitive function at 6 months after treatment. [Time frame: 6 months during follow-up]
Secondary outcome measures (12)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT06832839 · KY2024-112-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗