UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016407 |
|---|---|
| Receipt number | R000019056 |
| Scientific Title | Unusual sensation and sensorimotor functions in Autism spectrum disorders Study1:Decoding eye movement information for the understanding of its psychosocial functions |
| Date of disclosure of the study information | 2015/02/02 |
| Last modified on | 2017/08/15 08:16:52 |
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Basic information
Public title
Unusual sensation and sensorimotor functions in Autism spectrum disorders Study1:Decoding eye movement information for the understanding of its psychosocial functions
Acronym
Unusual sensation and sensorimotor functions in Autism spectrum disorders Study1: Eye movements
Scientific Title
Unusual sensation and sensorimotor functions in Autism spectrum disorders Study1:Decoding eye movement information for the understanding of its psychosocial functions
Scientific Title:Acronym
Unusual sensation and sensorimotor functions in Autism spectrum disorders Study1: Eye movements
Region
| Japan |
Condition
Condition
Autism spectrum disorder (ASD)
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this research is to explore the underlying mechanisms and psychosocial influence of eye movements specific to ASD.
Basic objectives2
Others
Basic objectives -Others
We also investigate unusual perceptual functions in connection with ASD specific eye movement patterns.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Behavioral data (eye movement, reaction time, error rate) and psychological tests
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Adults with ASD
Interventions/Control_2
Adults without ASD
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a) Adults with ASD
Adults who were diagnosed according to the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision (DSM-IV-TR) criteria for autism spectrum disorder
(a) Adults without ASD
Controls will be selected to match the ASD group as closely as possible on chronological age, gender, and full intelligence quotient (FIQ).
We explain the purpose of the study to each participant beforehand, and ask him/her to participate in our experiments only when the person understands the purpose of our research and is willing to take part in.
Key exclusion criteria
Subjects who are judged as unsuitable for participation in this study by their primary doctor (patients only)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Aya Shirama |
Organization
Nippon Telegraph and Telephone Corporation
Division name
NTT Communication Science Laboratories
Zip code
Address
3-1, Morinosato Wakamiya, Atsugi-shi, Kanagawa
TEL
046-240-3668
shirama.aya@lab.ntt.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aya Shirama |
Organization
Nippon Telegraph and Telephone Corporation
Division name
NTT Communication Science Laboratories
Zip code
Address
3-1, Morinosato Wakamiya, Atsugi-shi, Kanagawa
TEL
046-240-3668
Homepage URL
shirama.aya@lab.ntt.co.jp
Sponsor or person
Institute
Nippon Telegraph and Telephone Corporation, NTT Communication Science Laboratories
Institute
Department
Personal name
Funding Source
Organization
Nippon Telegraph and Telephone Corporation, NTT Communication Science Laboratories
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
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
昭和大学発達障害医療研究所
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 02 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 02 | 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
| 2015 | Year | 02 | Month | 01 | Day |
Last modified on
| 2017 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019056
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
