UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040051 |
|---|---|
| Receipt number | R000045662 |
| Scientific Title | Effectiveness of tablet-based cognitive training |
| Date of disclosure of the study information | 2020/04/04 |
| Last modified on | 2020/12/23 17:34:15 |
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Basic information
Public title
Effectiveness of tablet-based cognitive training
Acronym
Effectiveness of tablet-based cognitive training
Scientific Title
Effectiveness of tablet-based cognitive training
Scientific Title:Acronym
Effectiveness of tablet-based cognitive training
Region
| Japan |
Condition
Condition
Mood disorder
Anxiety disorder
Autism spectrum disorder
Attention deficit hyperactivity disorder
Mild cognitive impairment
Normal healthy control
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cognitive training has been thought to be a potential method to improve cognitive function. This training aims to maintain and improve cognitive function by repeatedly performing task (training) that requires cognitive function. Many cognitive training methods have been proposed, including working memory training, processing speed training, memory strategy training, reading and calculation training, and brain training games.
However, there are several issues in these traditional cognitive trainings. For instance, people need to purchase specialized and expensive equipment for the training . Participants have to visit universities and facilities with specialized staff. We thus need to develop cognitive training that has low implementation costs and can be easily implemented by anyone.
Cognitive training using smartphones and tablets may be attractive. Huge advantage over traditional training is that you can use the devices you are already using on a daily life and feel free to work at home at any time. Based on these social situation, we believe that examining the effects of cognitive training by using a tablet is of great social significance.
Therefore, in this study, we aimed to establish the usefulness of tablet-based cognitive training for psychiatric disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Clinical evaluation scale
HAM-D, HAM-A, MADRAS, etc.
2 Neuropsychological examination
TMT, BADS, CAT, CANTAB, etc.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
We conduct a maximum of 20 cognitive training at a pace of 4-5 days per week.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Patient group
People who were diagnosed with mood disorder, anxiety disorder, ASD, ADHD, MCI in DSM-5
2 Healthy control group
A healthy person without a history of mental illness
Key exclusion criteria
People who satisfies one of the following
1 Combined circulatory organ, liver, kidney, respiratory organs, blood, endocrine, central nervous system diseases, and person who was judged to be extremely unstable
2 Person who has history of head trauma or substance dependence
3 People with a history of epilepsy or generalized convulsions
4 For healthy control subjects, those who are diagnosed with developmental disorder
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Bun |
| Middle name | |
| Last name | Yamagata |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-Ku, Tokyo
TEL
03-5363-3971
yamagata@a6.keio.jp
Public contact
Name of contact person
| 1st name | Bun |
| Middle name | |
| Last name | Yamagata |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-Ku, Tokyo
TEL
03-5363-3971
Homepage URL
yamagata@a6.keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
None
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
Keio University School of Medicine, Institutional Review Board
Address
35 Shinanomachi Shinjuku-Ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.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
| 2020 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 04 | Day |
Last modified on
| 2020 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045662
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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