UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014745 |
|---|---|
| Receipt number | R000017141 |
| Scientific Title | The basic data for studying of elderly drivers characteristics |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2017/04/24 13:51:18 |
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Basic information
Public title
The basic data for studying of
elderly drivers characteristics
Acronym
elderly drivers characteristics
Scientific Title
The basic data for studying of
elderly drivers characteristics
Scientific Title:Acronym
elderly drivers characteristics
Region
| Japan |
Condition
Condition
Normal elderly,
Mild cognitive disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the elderly drivers characteristics in normal elderly and mild cognitive disorders used by both driving simulator, View Filed with Inhibitory Tasks and multi-modal neuroimaging analysis (structural and functional neuroimaging)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
driving simulator, View Filed with Inhibitory Tasks(VFIT), questionnaire,
diffusion tensor imaging (DTI), near-infrared spectroscopy (NIRS)
Key secondary outcomes
1 Cognitive assessment
Mini-Mental State Examination (MMSE)
Frontal assessment battery (FAB)
2 Behavior assessment
Driving behavior questionnaire (DBQ)
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The participants were performed with
cognitive assessment, questionnaire,
diffusion tensor imaging (DTI), near-infrared spectroscopy (NIRS)
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
normal elderly
mild cognitive disorders
Key exclusion criteria
A previous history of mental disorders,
the patient was taking antipsychotic drugs, the patient has pacemakers,
the patients with severe physical disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shutaro Nakaaki |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-3353-1211
hzi05510@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shutaro Nakaaki |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 Japan
TEL
03-3353-1211
Homepage URL
hzi05510@nifty.com
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University School of Medicine,
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
慶應義塾大学病院（東京都） Keio University School of Medicine (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 01 | Day |
Last modified on
| 2017 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017141
