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

February 12, 2025 updated by: Beijing Tiantan Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chaofan Zeng, MD
  • Phone Number: 8613693276138
  • Email: zchf723@163.com

Study Locations

  • China
      • Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months during follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
6, 12 and 24 months during follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 26, 2025

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2024-112-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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