UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006268 |
|---|---|
| Receipt number | R000007417 |
| Scientific Title | Study on maintenance and enhancement of cognitive functions affecting safety of driving |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2015/11/11 16:01:51 |
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Basic information
Public title
Study on maintenance and enhancement of cognitive functions affecting safety of driving
Acronym
Intervention study on cognitive functions and driving
Scientific Title
Study on maintenance and enhancement of cognitive functions affecting safety of driving
Scientific Title:Acronym
Intervention study on cognitive functions and driving
Region
| Japan |
Condition
Condition
Healthy drivers
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify cognitive functions which are influential on the safety of driving, and to develop training methods for those functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
* Driving aptitude test
* Composite measure of cognitive impairment
(all measured before and after the intervention.)
Key secondary outcomes
Brain structure and activity measured by MRI and MEG
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Participants conduct cognitive training (1) 20 minutes a day, 3 days per week, for 8 weeks.
Interventions/Control_2
Participants conduct cognitive training (2) 20 minutes a day, 3 days per week, for 8 weeks.
Interventions/Control_3
Participants conduct cognitive training (3) 20 minutes a day, 3 days per week, for 8 weeks.
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
| 60 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healty drivers of age 60-75
2. Right-handed person
3. Dwelling place: Sendai and its environs
Key exclusion criteria
1. People with medical history of psychotic disorders
2. People with medical history of neurological disorders
3. People suffering color vision deficiency
4. People with safety/measurement problem for MRI and MEG
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Nozawa |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Smart Aging International Research Center
Zip code
Address
Seiryo-machi 4-1, Aoba-ku, Sendai
TEL
022-717-7988
takayuki.nozawa.b5@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Nozawa |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Smart Aging International Research Center
Zip code
Address
Seiryo-machi 4-1, Aoba-ku, Sendai
TEL
022-717-7988
Homepage URL
takayuki.nozawa.b5@tohoku.ac.jp
Sponsor or person
Institute
Institute of Development, Aging and Cancer, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | 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
| 2011 | Year | 09 | Month | 01 | Day |
Last modified on
| 2015 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007417
