UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063405 |
|---|---|
| Receipt number | R000072565 |
| Scientific Title | Association Between Cerebral Perfusion Improvement and Changes in Cognitive Functions Following Revascularization Surgery in Adult Ischemic-Type Moyamoya Disease: A Prospective Cohort Study |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/10/25 01:05:54 |
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Basic information
Public title
Changes in Cognitive Functions Following Revascularization Surgery in Moyamoya Disease
Acronym
RECOG-MMD Study
Scientific Title
Association Between Cerebral Perfusion Improvement and Changes in Cognitive Functions Following Revascularization Surgery in Adult Ischemic-Type Moyamoya Disease: A Prospective Cohort Study
Scientific Title:Acronym
RECOG-MMD Study
Region
| Japan |
Condition
Condition
Moyamoya disease
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This prospective observational study aims to investigate the association between changes in cerebral perfusion and cognitive function following revascularization surgery in adults with ischemic-type moyamoya disease. Cognitive function is comprehensively assessed using the Wechsler Adult Intelligence Scale-Third Edition (WAIS-III), Mini-Mental State Examination (MMSE), Benton Visual Retention Test, Stroop Test, Trail Making Test (TMT), Rey Auditory Verbal Learning Test (RAVLT), and other neuropsychological assessments. Associations between changes in cognitive performance and cerebral perfusion measured by SPECT are evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between the change in Full-Scale Intelligence Quotient (FSIQ), assessed using the WAIS-III, and the change in cerebral blood flow (CBF) and cerebrovascular reactivity (CVR), assessed using SPECT, from baseline to 6 months after revascularization surgery.
Key secondary outcomes
Changes in WAIS-III indices and neuropsychological test performance, including MMSE, Benton Visual Retention Test, Stroop Test, TMT, and RAVLT, from baseline to 6 months postoperatively.
Associations between changes in cerebral blood flow measured by SPECT and changes in individual neuropsychological test scores.
Associations between hemispheric cerebral perfusion changes and changes in cognitive domains, including intellectual function, memory, attention, and executive function.
Associations between baseline cognitive performance and postoperative changes in cognitive function.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients aged 18 years or older diagnosed with moyamoya disease.
Patients who underwent extracranial-intracranial (EC-IC) bypass surgery.
Patients with a preoperative modified Rankin Scale (mRS) score of 0-2.
Patients with a preoperative Mini-Mental State Examination (MMSE) score of 26 or higher.
Patients who were able to undergo cerebral blood flow assessment using SPECT and cognitive function assessment using neuropsychological tests both before and after surgery.
Key exclusion criteria
Patients with a preoperative modified Rankin Scale (mRS) score of 3 or higher.
Patients with a preoperative Mini-Mental State Examination (MMSE) score of 25 or lower.
Patients with neurological deficits, including aphasia, severe motor impairment, or visual impairment, that precluded reliable neuropsychological assessment.
Patients for whom preoperative or postoperative SPECT data or neuropsychological assessment data were unavailable.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | TAICHI |
| Middle name | |
| Last name | ISHIGURO |
Organization
Tokyo Women's Medical University Yachiyo Medical Center
Division name
Department of Neurosurgery
Zip code
2768524
Address
Owadashinden 477-96, Yachiyo, Chiba, Japan
TEL
047-450-6000
ishiguro.taichi@twmu.ac.jp
Public contact
Name of contact person
| 1st name | TAICHI |
| Middle name | |
| Last name | ISHIGURO |
Organization
Tokyo Women's Medical University Yachiyo Medical Center
Division name
Department of Neurosurgery
Zip code
2768524
Address
477-96 Owadashinden, Yachiyo, Chiba, Japan
TEL
0474506000
Homepage URL
ishiguro.taichi@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University Yachiyo Medical Center
Institute
Department
Personal name
Taichi Ishiguro
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Women's Medical University
Address
Kawadacho 8-1, Shinjuku, Tokyo, Japan
Tel
0333538111
ishiguro.taichi@twmu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
62
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational study involving adult patients with moyamoya disease who underwent extracranial-intracranial (EC-IC) bypass surgery. Cerebral blood flow and cognitive function were assessed before surgery and at 6 months postoperatively using single-photon emission computed tomography (SPECT) and comprehensive neuropsychological assessments, respectively.
Cognitive function was evaluated using the Wechsler Adult Intelligence Scale-Third Edition (WAIS-III), Mini-Mental State Examination (MMSE), Benton Visual Retention Test, Stroop Test, Trail Making Test (TMT), Rey Auditory Verbal Learning Test (RAVLT), and other neuropsychological assessments.
Changes in cerebral blood flow and cognitive function were evaluated before and after surgery, and the associations between improvements in cerebral perfusion and changes in cognitive performance were investigated. Revascularization surgery was performed as part of routine clinical care, without study-specific treatment allocation or modification.
The study was conducted prospectively and is being registered with the UMIN Clinical Trials Registry (UMIN-CTR) after completion of the observation period.
Management information
Registered date
| 2026 | Year | 10 | Month | 25 | Day |
Last modified on
| 2026 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072565
