UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051657 |
|---|---|
| Receipt number | R000058931 |
| Scientific Title | Measuring cognitive function and personality traits using eye tracking |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2024/01/19 17:24:47 |
* 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
Public title
Measuring cognitive function and personality traits using eye tracking
Acronym
ET study
Scientific Title
Measuring cognitive function and personality traits using eye tracking
Scientific Title:Acronym
ET study
Region
| Japan |
Condition
Condition
Patient(Mild cognitive impairment, dementia), healthy people
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to analyze eye movements while playing a simple computer game or looking at images in dementia patients, elderly people in the community, and workers, and to clarify the relationship between eye movements and known cognitive function tests and assessment indices related to personality traits.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between the total amount of eye movement during the game and general cognitive function scores
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To let the user play a simple computer game or view images.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Selection Criteria for Persons with Dementia and Mild Cognitive Impairment:Persons who are at least 18 years of age at the time of study entry and have a diagnosis of mild cognitive impairment or dementia.
Selection criteria for healthy individuals: 18 years of age or older at the time of study participation.
Key exclusion criteria
Exclusion criteria for persons with dementia and mild cognitive impairment: 1.
1. those who have difficulty in recognizing the images presented due to visual impairment
2. those with mood disorders, schizophrenia, or intellectual disability
Exclusion criteria for healthy individuals
1. who have difficulty perceiving the images presented due to visual impairment
2. who have mood disorder, schizophrenia, or intellectual disability
3. who have ever been diagnosed with dementia
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Jumpei |
| Middle name | |
| Last name | Maruta |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Neuropsychiatry
Zip code
545-8585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-2121
j_maruta@omu.ac.jp
Public contact
Name of contact person
| 1st name | Jumpei |
| Middle name | |
| Last name | Maruta |
Organization
Osaka Metropolitan University Graduate School of Medicine
Division name
Department of Neuropsychiatry
Zip code
545-8585
Address
1-5-7, Asahimatchi, Abeno-ku, Osaka City
TEL
06-6645-2121
Homepage URL
j_maruta@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Iida Sangyo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka Metropolitan University Graduate School of Medicine
Address
1-2-7, Asahimachi, Abeno-ku, Osaka
Tel
06-6645-3456
gr-a-knky-ethics@omu.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
| 2023 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | 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
| 2023 | Year | 07 | Month | 20 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058931
