UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016534 |
|---|---|
| Receipt number | R000019194 |
| Scientific Title | Effects of prolonged working memory training on functions, structures and omics |
| Date of disclosure of the study information | 2015/02/15 |
| Last modified on | 2023/08/22 12:42:17 |
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Basic information
Public title
Effects of prolonged working memory training on functions, structures and omics
Acronym
Effects of prolonged working memory training on functions, structures and omics
Scientific Title
Effects of prolonged working memory training on functions, structures and omics
Scientific Title:Acronym
Effects of prolonged working memory training on functions, structures and omics
Region
| Japan |
Condition
Condition
the healthy young
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the effects of prolonged WMT on
(a) cognitive functions
(b) individual traits
(c) epigenetics and proteomics
(d) neural change
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
EQSQ questionnaires, well being scale, GPS, TPS, envy tendency scale, affiliation tendency scale, trust scale, groupism scale, preoccupation scale, justice world scale, sex role eagalitalianism scale, identifity scale, love scale, future meditation scale, IRI scale, agency scale, Schizotypal Personality Questionnaire, BIS, thankful scale, psychopathy scale, Machiavellism scale, social comparison tendency scale, hardiness scale, psychopathy scale, a questionnaire about imagination, tiredness scale, TCI, NEO-FFI, CARRS, POMS, cognitive reflectivity-impulsiveness scale, guilty scale, self conciousness scale, cognitive desire, achievement motivation scale, need for uniqueness scale, natinalism scale, locus of control scale, sexual attitude scale, optimism scale, self efficacy scale, self handicapping scale, Japanese type A scale, learning motivation scale, dysexecutive questionnaire,
STAXI, critical thinking scale, Rosesnberg self esteem scale, Check list Strength,STAI, Beck's depression scale, paranoia checklist, percieved stress scale, delay discounting scale, GHQ30,QOL26,EQS
computerized working memory tasks, Raven's advanced progressive matrix test, reading comprehension test, Tanaka's intelligence test type B, Stroop test, S-A creativity test, remote associate test, epigenetics, protemics, brain volume, brain microstructurl property, cerebral blood flow, functional connectivitiy, brain activation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
playing a soft called "oni-training"
about a year
3 tasks, oni-keisan, oni-block, oni-mimizan.
As many times as possible.
Interventions/Control_2
playing a soft called "bimoji-training"
about a year.
playing the "all letters" training mode. play for 20 minutes.
As many times as possible.
Interventions/Control_3
no-intervention.
about a year.
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
| 18 | years-old | <= |
Age-upper limit
| 27 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
right handedness. 18-27 year old. Japanese native speakers. Students of Tohoku university, Miyagi education university, and graduate school or equivalent or more than equivalent level of schools. no experience of faint during blood sampling. no experience of shodo except at school education, oni-training, can participate in the experiment a year later, can play DS games for 20 minuets for more than 70-80% of the all days.
Key exclusion criteria
Metal in and around the body.
Claustrophobia. Possibility of pregnancy.
Target sample size
165
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Kawashima |
Organization
IDAC, Tohoku University.
Division name
Department of functional imaging.
Zip code
980-8575
Address
4-1, Seiryo-cho, Sendai city, Aoba-ku
TEL
022-717-7988
ryuta@idac.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Takeuchi |
Organization
IDAC, Tohoku University
Division name
Division of developmental cognitive neuroscience
Zip code
980-8575
Address
4-1, Seiryo-cho, Aoba-ku, Sendai city
TEL
022-717-8457
Homepage URL
takehi@idac.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university
Institute
Department
Personal name
Funding Source
Organization
chizaisozokeihi, nintendo's collaborative research fund, kakenhi
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku university school of medicine, ethics committee
Address
Tohoku university school of medicine, Seiryo-cho 2-1, Aoba-ward, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@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
| 2015 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
analyzing
Publication of results
Unpublished
Result
URL related to results and publications
analyzing
Number of participants that the trial has enrolled
180
Results
analyzing
Results date posted
| 2019 | Year | 08 | Month | 29 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
busy
Date of the first journal publication of results
Baseline Characteristics
analyzing
Participant flow
analyzing
Adverse events
analyzing
Outcome measures
analyzing
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2033 | Year | 08 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 13 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019194
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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