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NCT Number: NCT06832839

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Revascularization

Procedure

Revascularization

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in composite score of neurocognitive function at 12 and 24 months after treatment.

    Time frame: 12 and 24 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 12 and 24 months after treatment.

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chaofan Zeng, MD

CONTACT

[email protected]

8613693276138

Qian Zhang, MD

CONTACT

[email protected]

8613120012579

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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