UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038436 |
|---|---|
| Receipt number | 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 | 2025/05/08 09:44:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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/Mild cognitive impairment
Classification by specialty
| Neurology | 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
4
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
4) Drivers with mild cognitive impairment
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_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
120
Research contact person
Name of lead principal investigator
| 1st name | Makiko |
| Middle name | |
| Last name | Yamada |
Organization
National Institutes for Quantum Science and Technology
Division name
Advanced Neuroimaging Center
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 | Yasunori |
| Middle name | |
| Last name | Aizawa |
Organization
National Institutes for Quantum Science and Technology
Division name
Advanced Neuroimaging Center
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-3025
Homepage URL
aizawa.yasunori@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
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
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
Completed
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
| 2025 | 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
| 2025 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043797
