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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036878
Receipt No. R000042019
Scientific Title Examination of the information processing during driving simulation
Date of disclosure of the study information 2019/05/29
Last modified on 2019/05/29

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Basic information
Public title Examination of the information processing during driving simulation
Acronym Examination of the information processing during driving simulation
Scientific Title Examination of the information processing during driving simulation
Scientific Title:Acronym Examination of the information processing during driving simulation
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to understand the information-processing during driving simulation using fMRI.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between driving operation, eye-movement, and BOLD signal in the region of the brain that is involved with information-processing during a driving simulation.
Key secondary outcomes

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 Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Informed consent (30min)
Psychological test (65min)
MRI scan (85min)
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
60 years-old >
Gender Male
Key inclusion criteria Test driver who is familiar with driving using a simulator.
Key exclusion criteria Organic brain disease
Substance related disorders
Serious medical illness
Target sample size 20

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 Haruki
Middle name
Last name Nishimura
Organization 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 043-206-3025
Homepage URL
Email nishimura.haruki@qst.go.jp

Sponsor
Institute Honda R&D Co., LTD.
Institute
Department

Funding Source
Organization Honda R&D Co., LTD.
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 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 05 Month 29 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 22
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 Completed
Date of protocol fixation
2018 Year 10 Month 31 Day
Date of IRB
2018 Year 10 Month 31 Day
Anticipated trial start date
2018 Year 10 Month 31 Day
Last follow-up date
2019 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 05 Month 28 Day
Last modified on
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042019

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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