UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000022250
Receipt No. R000025637
Official scientific title of the study Beneficial effects of tablet PC on cognitive function in the health elderly
Date of disclosure of the study information 2016/05/10
Last modified on 2016/11/08 (Ver. 2)

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Basic information
Official scientific title of the study Beneficial effects of tablet PC on cognitive function in the health elderly
Title of the study (Brief title) Beneficial effects of tablet PC
Region
Japan

Condition
Condition The healthy elderly
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the beneficial effects of processing speed training using Tablet PC on cognitive functions in the elderly
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Raven matrix test, digit span, story memory, Digit Symbol Coding (Cd) , Symbol Search(SS)(4 weeks after)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment Behavior,custom Other
Interventions/Control_1 Processing speed game intervention using tablet PC(15 minutes, 5 days per a week for 4 weeks)
Interventions/Control_2 Semantic knowledge game intervention using tablet PC(15 minutes, 5 days per a week 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
Age-lower limit
60 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria We include participants who will report to be right-handed, native Japanese speakers, not concerned about their own memory functions, not using medications known to interfere with cognitive functions (including benzodiazepines, antidepressants or other central nervous agents), and having no diseases known to affect the central nervous system, including thyroid disease, multiple sclerosis, Parkinson's disease, stroke, severe hypertension or diabetes.
Key exclusion criteria Person with medical history of the cerebral nerve disease
Person with medical history such as high blood pressure, the diabetes
Person who is participating in another cognitive-related training
Target sample size 72

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 022-717-8466
Email rui.nouchi.a4@tohoku.ac.jp

Public contact
Name of contact person 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 022-717-8466
Homepage URL
Email rui.nouchi.a4@tohoku.ac.jp

Sponsor
Institute Tohoku Univeristy
Institute
Department

Funding Source
Organization Sharp Corporation
Organization
Division
Category of Funding Organization Profit organization
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
2016 Year 05 Month 10 Day

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 04 Month 01 Day
Anticipated trial start date
2016 Year 04 Month 06 Day
Last follow-up date
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
2016 Year 05 Month 09 Day
Last modified on
2016 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025637