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Recruitment status Completed
Unique ID issued by UMIN UMIN000002825
Receipt No. R000003447
Official scientific title of the study The efficacy of playing the Ninntendo DS games on cognitive functions of healthy elderly: a randomaized controlled trial.
Date of disclosure of the study information 2009/12/02
Last modified on 2011/04/07

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

Objectives
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
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
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
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
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
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
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
Institute Institute of Development, Aging and Cancer, Tohoku University
Institute
Department

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
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)

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
2009 Year 12 Month 02 Day

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

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Publication of results Unpublished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

Management information
Registered date
2009 Year 12 Month 02 Day
Last modified on
2011 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003447


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