UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020819 |
|---|---|
| Receipt number | R000023904 |
| Scientific Title | Evaluation of driving ability using an actual vehicle in older adults. |
| Date of disclosure of the study information | 2016/03/01 |
| Last modified on | 2020/12/23 17:23:31 |
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Basic information
Public title
Evaluation of driving ability using an actual vehicle in older adults.
Acronym
Evaluation of driving ability in older adults
Scientific Title
Evaluation of driving ability using an actual vehicle in older adults.
Scientific Title:Acronym
Evaluation of driving ability in older adults
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the neurobiological substrates associated with the driving ability of mild cognitive impairment using driving test and neuroimaging techniques.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between driving ability and neuroimaging findings.
Key secondary outcomes
Driving ability
1. Evaluation of driving skills in the same scoring method as driving test using an actual vehicle
Neuroimaging techniques include
1. Functional MRI
2. Structural MRI
3. DTI (diffusion tensor imaging)
4. NIRS (near-infrared spectroscopy)
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
| Other |
Interventions/Control_1
Comparing the driving skill test using an actual vehicle between participants with mild cognitive impairment and healthy elderly controls.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Participants diagnosed with mild cognitive impairment at Keio University Hospital
2. Healthy controls scored more than 24 points in MMSE
3. Reliable informed consent could be obtained from the patient and or his her relatives
Key exclusion criteria
1. Participants were required to have had no lifetime history of any psychiatric disorders, or drug or alcohol misuse, as well as no neurological disorder
2. none of the participants reported unstable medical condition and history of significant head trauma.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Mimura |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-Ku, Tokyo
TEL
03-3353-1211
mimura@a7.keio.jp
Public contact
Name of contact person
| 1st name | Bun |
| Middle name | |
| Last name | Yamagata |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-Ku, Tokyo
TEL
03-5363-3971
Homepage URL
yamagata@a6.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi Shinjuku-Ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2016 | Year | 03 | Month | 01 | 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
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 01 | Day |
Last modified on
| 2020 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023904
