UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034359 |
|---|---|
| Receipt number | R000039061 |
| Scientific Title | Typical and Atypical Development of Attentional Bias to Human: a Change Blindness study. |
| Date of disclosure of the study information | 2018/10/15 |
| Last modified on | 2018/10/02 16:54:18 |
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Basic information
Public title
Typical and Atypical Development of Attentional Bias to Human: a Change Blindness study.
Acronym
Development of Attentional Bias to Human
Scientific Title
Typical and Atypical Development of Attentional Bias to Human: a Change Blindness study.
Scientific Title:Acronym
Development of Attentional Bias to Human
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the developmental change of attentional bias to human in individuals with and without autism spectrum disorder.
Basic objectives2
Others
Basic objectives -Others
To reveal the specific brain region relating to development of attentional bias to human using functional MRI and eye tracking techniques.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Task performance, eye movements and brain imaging.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Children, adolescents and adults with Autism Spectrum Disorder.
Interventions/Control_2
Healthy children, adolescents and adults.
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
| 5 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Male
Key inclusion criteria
Patients
1. Children, adolescents and adults who were diagnosed as autism spectrum disorder based on DSM-5, and confirmed the diagnosis by AQ.
2. Children, adolescents and adults who do not have any severe neuropsychiatric disorders and physical illness.
3. Children, adolescents and adults whose IQs are above 70, and who can give informed consent.
Typical control
1. Children, adolescents and adults who do not have any severe neuropsychiatric disorders and physical illness.
2. Children, adolescents and adults whose IQs are above 70, and who can give informed consent.
Key exclusion criteria
Children, adolescents and adults who have diagnosed as neuropsychiatric disorder or intellectual disorder, who are extreme myopia, who cannot have an MRI scan and ability to consent or regulate their own body temperatures.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryuta Kawashima |
Organization
Institute of Development, Aging and Cancer, Tohoku University
Division name
Department of Functional Brain Imaging
Zip code
Address
4-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL
022-717-7988
ryuta@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Kobayashi |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Functional Brain Imaging
Zip code
Address
4-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL
022-717-8466
Homepage URL
akiko.kobayashi.q6@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 10 | Month | 15 | 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 | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | 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
Management information
Registered date
| 2018 | Year | 10 | Month | 02 | Day |
Last modified on
| 2018 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039061
