UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036878 |
|---|---|
| Receipt number | 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 14:26:11 |
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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
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
nishimura.haruki@qst.go.jp
Sponsor or person
Institute
Honda R&D Co., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042019
