Study on the Mechanism of Cognitive Impairment in Patients with Moyamoya Disease
ConditionMoyamoya Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Revascularization
Procedure/SurgeryRevascularization
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
6 months during follow-upSecondary outcomes
1
Changes in composite score of neurocognitive function at 12 and 24 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 12 and 24 months after treatment.
Time frame
12 and 24 months during follow-up2
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-up3
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-up4
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-upSponsors and contacts
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Source ClinicalTrials.gov