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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030362
Receipt No. R000034667
Scientific Title Establishment of neurocognitive training to improve frontal lobe function in moyamoya disease
Date of disclosure of the study information 2017/12/12
Last modified on 2020/02/17

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Basic information
Public title Establishment of neurocognitive training to improve frontal lobe function in moyamoya disease
Acronym Establishment of neurocognitive training to improve frontal lobe function in moyamoya disease
Scientific Title Establishment of neurocognitive training to improve frontal lobe function in moyamoya disease
Scientific Title:Acronym Establishment of neurocognitive training to improve frontal lobe function in moyamoya disease
Region
Japan

Condition
Condition moyamoya disease
Classification by specialty
Radiology Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the changes in neuropsychological test performance, and the morphological and functional changes of the brain, following neurocognitive training in moyamoya disease patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Percentage of correct answers in the PASAT score before and after the neurocognitive training and the magnitude of change in the scores
Key secondary outcomes 1.Pre- and post-neurocognitive training neuropsychological test results (trail making test part A and B, digit span test, tapping span test, standard verbal paired-associate learning test scores)and the magnitude of change
2.Pre- and post-training morphological and functional imaging results and the magnitude of change
3.Correlation between the morphological and functional imaging results and the neuropsychological performance (the magnitude of change in each score before and after training)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Neurocognitive training
1 hour/session, 5 sessions/week for 4 weeks, a total of 20 hours
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients between 20 and 65 years of age at the time of consent
2.Those who were diagnosed as moyamoya disease according to the guidelines of MMD proposed by the Research Committee on spontaneous occlusion of the circle of Willis
3.Those patients who gave informed consent based on own will or the will of a guardian
Key exclusion criteria 1.Quasimoyamoya syndrome with conditions such as Down syndrome and neurofibromatosis
2.Stroke with neurological deficit
3.Psychological or neurological disorders which affect the neuropsychological test performance
4.Vision or hearing impairment or motor disability which affects the neuropsychological test performance
5.Contraindications for MRI (cardiac pacemaker, inner ear implant, claustrophobia, etc)
6.Revascularization surgery before the study
7.Conditions in which the principal investigator considers not suitable for participation in the study
Target sample size 21

Research contact person
Name of lead principal investigator
1st name Khin Khin
Middle name
Last name Tha
Organization Hokkaido University Hospital
Division name Department of diagnostic and interventional radiology
Zip code 060-8648
Address Kita14, Nishi5, Kita-ku, Sapporo
TEL 011-706-5977
Email kktha@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Sawamura
Organization Hokkaido University
Division name Graduate School of Biomedical Science and Engineering
Zip code 060-0812
Address Kita14, Nishi5, Kita-ku, Sapporo
TEL 011-706-8183
Homepage URL
Email dai-sawa@hoku-iryo-u.ac.jp

Sponsor
Institute Hokkaido University Hospital,
Department of diagnostic and interventional radiology
Institute
Department

Funding Source
Organization Hokkaido University Hospital,
Department of diagnostic and interventional radiology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Hokkaido University Hospital
Address kita-14, nishi-5, Kita-ku
Tel 011-706-7636
Email crjimu@huhp.hokudai.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
2017 Year 12 Month 12 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
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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 12 Day
Date of IRB
2017 Year 12 Month 14 Day
Anticipated trial start date
2017 Year 12 Month 19 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 12 Day
Last modified on
2020 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034667

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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