UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033470
Receipt number 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 2020/07/24 15:26:00

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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 Takahito
Middle name
Last name Wada

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Medical Ethics and Medical Genetics

Zip code

606-8501

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 Takahito
Middle name
Last name Wada

Organization

Kyoto University Graduate School of Medicine

Division name

Department of Medical Ethics and Medical Genetics

Zip code

606-8501

Address

Yoshida-Konoe-cho, Sakyo-ku,, Kyoto, Japan

TEL

075-753-4648

Homepage URL


Email

wadataka@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



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

Kyoto University Graduate School and Faculty of Medicine Ethics Comittee

Address

Yoshida Konoe-cho, Sakyoku, Kyoto, 606-8501, Japan

Tel

075-753-4648

Email

ethcom@kuhp.kyoto-u.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

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

Open public recruiting

Date of protocol fixation

2018 Year 08 Month 01 Day

Date of IRB

2018 Year 10 Month 16 Day

Anticipated trial start date

2019 Year 04 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

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

2020 Year 07 Month 24 Day



Link to view the page

Value
https://center6.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