UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058915 |
|---|---|
| Receipt number | R000067380 |
| Scientific Title | A Survey and Intervention Study on the Relationship between Driving and Brain Health |
| Date of disclosure of the study information | 2025/08/29 |
| Last modified on | 2025/08/28 11:49:07 |
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Basic information
Public title
A Survey and Intervention Study on the Relationship between Driving and Brain Health
Acronym
A Survey and Intervention Study on the Relationship between Driving and Brain Health
Scientific Title
A Survey and Intervention Study on the Relationship between Driving and Brain Health
Scientific Title:Acronym
Driving and Brain Health
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We'll examine how driving affects brain health by identifying the driving maneuvers related to cognitive and psychological well-being in men and women in their 40s and 50s, and then conducting a driving skills training that includes these maneuvers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For a 3-month intervention period. We'll assess cognitive function using the following:Addenbrooke's Cognitive Examination-III,Flanker task,Stroop test,n-back task,TMT-A/B,Mental rotation test
Key secondary outcomes
Psychological scale, Fatigue scale, Motor function assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
You will conduct a total of 10 driving skills training sessions at a driving school over a six-month period. Each training session will last about 30 minutes.
Interventions/Control_2
Control
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
| 40 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who regularly drive a car for commuting or other purposes
Individuals who can continue attending driving skills training at a driving school for six months during the study period
Individuals who have provided written consent to participate in the study
Key exclusion criteria
Individuals who have not provided informed consent
Individuals with a history of or current diagnosis of dementia or other psychiatric/neurological disorders
Individuals with severe visual or hearing impairments
Individuals currently participating in another clinical study
Any other individual for whom study participation would be difficult
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Department of Smart-Aging Research Center
Zip code
980-8575
Address
4-1 Seiryo-Cho, Aoba-ku, Sendai City, Miyagi
TEL
022-717-8556
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Ryuichi |
| Middle name | |
| Last name | Kasahara |
Organization
Tohoku University
Division name
Department of Smart-Aging Research Center
Zip code
980-8575
Address
4-1 Seiryo-Cho, Aoba-ku, Sendai City, Miyagi
TEL
022-717-8824
Homepage URL
ryuichi.kasahara.c1@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
SUBARU
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
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 28 | Day |
Last modified on
| 2025 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067380
