NCT06832839

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Dec 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Dec 2024Dec 2027

Study Start

First participant enrolled

December 16, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 26, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

February 18, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 26, 2025

Last Update Submit

February 12, 2025

Conditions

Moyamoya Disease

Keywords

Cognitive ImpairmentMoyamoya Disease

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (14)

  • 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

  • +9 more secondary outcomes

Interventions

RevascularizationPROCEDURE

Revascularization

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China, 100070, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Moyamoya DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Central Study Contacts

Qian Zhang, MD

CONTACT

8613120012579zhangqianchina@yahoo.com

Chaofan Zeng, MD

CONTACT

8613693276138zchf723@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2025

First Posted

February 18, 2025

Study Start

December 16, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

February 18, 2025

Record last verified: 2025-01

Locations

CN(1)