UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055480 |
|---|---|
| Receipt number | R000063389 |
| Scientific Title | Study on the effects of stress reduction through a traffic accident reduction application on brain function |
| Date of disclosure of the study information | 2024/09/17 |
| Last modified on | 2025/03/13 11:23:58 |
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Basic information
Public title
Effects of Stress Reduction Through a Traffic Accident Prevention App on Brain Structure and Accident Rates in Driving Simulator Tests
Acronym
Traffic Accident Reduction Application and Brain Function Study
Scientific Title
Study on the effects of stress reduction through a traffic accident reduction application on brain function
Scientific Title:Acronym
Traffic Accident Reduction Application and Brain Function Study
Region
| Japan |
Condition
Condition
Adult men and women over the age of 18
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of a stress mitigation intervention via a traffic accident reduction app on the brain structure and the number of accidents in a driving simulator.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scores on the stress-related questionnaire
Number of accidents in the driving simulator
Hippocampal structure in T1-weighted images
White matter fiber structure in diffusion tensor imaging (DTI)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Using a traffic accident reduction application with auditory, visual, and vibratory stimuli.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult men and women over the age of 20 who drive on a daily basis.
Key exclusion criteria
Individuals with severe cognitive impairment and severe higher brain function impairment
Individuals with developmental disabilities who also have dementia and higher brain function impairments
Individuals with claustrophobia
Individuals with metal implants in their body
Pregnant individuals
Individuals currently participating in other clinical studies
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart Aging International Research Center
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8582
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Takuji |
| Middle name | |
| Last name | Kawamura |
Organization
Tohoku University
Division name
Smart Aging International Research Center
Zip code
980-8575
Address
4-1 Seiryo-Machi, Aoba-ku,Sendai
TEL
022-717-8824
Homepage URL
takuji.kawamura.b8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
SDNC Corporation
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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
東北大学 スマート・エイジング学際重点研究センター
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | 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
| 2024 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063389
