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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038436
Receipt No. R000043797
Scientific Title A study of brain activity during simulated driving and corresponding cognitive functions.
Date of disclosure of the study information 2019/11/15
Last modified on 2020/04/30

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Basic information
Public title A study of brain activity during simulated driving and corresponding cognitive functions.
Acronym A study of brain activity during simulated driving and corresponding cognitive functions.
Scientific Title A study of brain activity during simulated driving and corresponding cognitive functions.
Scientific Title:Acronym A study of brain activity during simulated driving and corresponding cognitive functions.
Region
Japan

Condition
Condition Healthy individuals
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A study of brain activity during simulated driving and corresponding cognitive functions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The correlation between the change of BOLD signals, the driving manipulation and the cognitive functions.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 1) Ordinary drivers
Day1
Screening test: 10min
Break time
Cognitive test: 90min
Break time
Psychological test:80min

Day2
MRI scan: 30min
Break time
MRI scan: 90min
Break time
MRI scan: 90min

Interventions/Control_2 2) Old drivers
Day1
Screening test: 10min
Break time
Cognitive test: 90min
Break time
Psychological test:80min

Day2
MRI scan: 30min
Break time
MRI scan: 90min
Break time
MRI scan: 90min
Interventions/Control_3 3) Risk minimum drivers
Day1
Screening test: 10min

Day2
Cognitive test: 90min
Break time
Psychological test:80min

Day3
MRI scan: 30min
Break time
MRI scan: 90min
Break time
MRI scan: 90min
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy individuals who have the ability to provide informed consent.
Key exclusion criteria Psychiatric disorders including drug dependence
Serious medical illness
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Makiko
Middle name
Last name Yamada
Organization National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
Division name Department of Functional Brain Imaging Research
Zip code 263-8555
Address 4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL 043-206-3251
Email yamada.makiko@qst.go.jp

Public contact
Name of contact person
1st name Yasunori
Middle name
Last name Aizawa
Organization National Institutes for Quantum and Radiological Science and Technology National Institute of Radio
Division name Department of Functional Brain Imaging Research
Zip code 263-8555
Address 4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL 043-206-3025
Homepage URL
Email aizawa.yasunori@qst.go.jp

Sponsor
Institute National Institutes for Quantum and Radiological Science and Technology
National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization Honda R&D Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Certified Review Board
Address 4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
Tel 043-206-4709
Email helsinki@qst.go.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
2019 Year 11 Month 15 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
2019 Year 10 Month 29 Day
Date of IRB
2019 Year 10 Month 29 Day
Anticipated trial start date
2019 Year 11 Month 20 Day
Last follow-up date
2022 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
2019 Year 10 Month 30 Day
Last modified on
2020 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043797

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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