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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033470
Receipt No. R000038165
Scientific Title Study to evaluate the cognitive function by analyzing eye-gazze pattern
Date of disclosure of the study information 2018/09/01
Last modified on 2018/07/22

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Basic information
Public title Study to evaluate the cognitive function by analyzing eye-gazze pattern
Acronym Study to evaluate the cognitive function by analyzing eye-gazze pattern
Scientific Title Study to evaluate the cognitive function by analyzing eye-gazze pattern
Scientific Title:Acronym Study to evaluate the cognitive function by analyzing eye-gazze pattern
Region
Japan

Condition
Condition intellectual disability syndromes
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This is a study to avaluate cognitive function of patients with intellectual disability by evaluating eye-gaze patterns.
Basic objectives2 Others
Basic objectives -Others developmental stage, language ability, communication ability, quality of ordinary life
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes eye-gaze patterns by using Gazefinder
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with intellectual disabilities, and without intellectual disability
Key exclusion criteria patients with poor eyesight
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahito Wada
Organization Kyoto University Graduate School of Medicine
Division name Department of Medical Ethics and Medical Genetics
Zip code
Address Yoshida-Konoe-cho, Sakyo-ku,, Kyoto, Japan
TEL 075-753-4648
Email wadataka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahito Wada
Organization Kyoto University Graduate School of Medicine
Division name Department of Medical Ethics and Medical Genetics
Zip code
Address Yoshida-Konoe-cho, Sakyo-ku,, Kyoto, Japan
TEL 075-753-4648
Homepage URL
Email wadataka@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Kyoto University
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 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
2018 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study to evaluate eye-gaze patterns using Gazefinder

Management information
Registered date
2018 Year 07 Month 22 Day
Last modified on
2018 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038165

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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