UMIN-CTR Clinical Trial


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Recruitment
status
Completed
Unique trial Number : UMIN000002825
Title of the study : The efficacy of playing the Ninntendo DS games on cognitive functions of healthy elderly: a randomaized controlled trial.
Date of formal registration
(=Date of ICMJE and WHO compliant trial information registration and disclosure)
: 2009/12/02
Date and time of last update : 2011/04/07 09:59:05

This page includes information on clinical trials registered in UMIN clinical trial registed system.
We don't aim to advertise certain products or treatments.

Basic information
Item Value
Official scientific title of the study The efficacy of playing the Ninntendo DS games on cognitive functions of healthy elderly: a randomaized controlled trial.
Title of the study (Brief title) The efficacy of playing games on cognitive functions.
Region Japan


Condition
Item Value
Condition Healthy elderly
Classification by specialty Psychiatry
Classification by malignancy Others
Genomic information NO


Objectives
Item Value
Narrative objectives1 Our aim is to investigate the effects of intervention of Nintendo DS on cognitive functions of healthy elderly
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase


Assessment
Item Value
Primary outcomes 1)Mini-Mental State Examination (MMSE)
2)Frontal assessment battery at bedside (FAB)
3)Trail Making Test-B (TMT-B)
4)Digit cancellation task (D-CAT
5)digit span forward (DS-F)
6)digit span backward (DS-B)
7)Digit Symbol Coding (Cd)
8)Symbol Search (SS)
Key secondary outcomes 1)Brain structure measured by MRI


Base
Item Value
Study type Interventional


Study design
Item Value
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know


Intervention
Item Value
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention Behavior,custom
Interventions/Control_1 Playing a brain training game once a day, and 15 minutes for 4 weeks
Interventions/Control_2 Playing a puzzle game once a day, and 15 minutes for 4 weeks
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
Item Value
Age-lower limit 65 years-old <=
Age-upper limit 75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Age:65-75
2.Right-handed person

Key exclusion criteria 1.Person whom has metal in the body(ex. a pacemaker, an aneurysm clip)
2.Person without medical history of the cerebral nerve disease
3.Person without medical history such as high blood pressure, the diabetes
Target sample size 32


Research contact person
Item Value
Name of lead principal investigator Rui Nouchi
Organization Institute of Development, Aging and Cancer, Tohoku University
Division name Smart Aging International Research Center
Address Seiryo-machi 4-1, Aoba-ku Sendai
TEL
Email


Public contact
Item Value
Name of contact person
Organization Institute of Development, Aging and Cancer, Tohoku University
Division name Smart Aging International Research Center
Address Seiryo-machi 4-1, Aoba-ku Sendai
TEL
Homepage URL
Email


Sponsor
Item Value
Name of primary sponsor Institute of Development, Aging and Cancer, Tohoku University

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean "funding agency". Therefore, all clinical trial should have the one.


Funding Source
Item Value
Source of funding Tohoku University
Category of Org. Self funding
Nation of funding


Other related organizations
Item Value
Name of secondary sponsor(s)
Name of secondary funder(s)


Secondary study IDs
Item Value
Secondary study IDs NO
Secondary study ID_1
Org. issuing Secondary study ID_1
Secondary study ID_2
Org. issuing Secondary study ID_2
IND to MHLW


Institutions
Item Value
Institutions


Progress
Item Value
Recruitment status Completed
Date of protocol fixation 2009/11/30
Anticipated trial start date 2010/01/01
Last follow-up date 2010/08/01
Date of closure to data entry
Date trial data considered complete
Date analysis concluded


Related information
Item Value
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information


Item Value
Date of registration 2009/12/02
Date of last update 2011/04/07 09:59:05


Link to view
URL(Japanese) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000003447&type=summary&language=J
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000003447&type=summary&language=E
This page includes information on clinical trials registered in UMIN clinical trial registed system.
We don't aim to advertise certain products or treatments.