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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014776
Receipt No. R000017182
Scientific Title A cognitive neuroscience study of metacognition in autism spectrum disorder
Date of disclosure of the study information 2014/08/06
Last modified on 2018/02/07

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Basic information
Public title A cognitive neuroscience study of metacognition in autism spectrum disorder
Acronym A cognitive neuroscience study of metacognition in ASD
Scientific Title A cognitive neuroscience study of metacognition in autism spectrum disorder
Scientific Title:Acronym A cognitive neuroscience study of metacognition in ASD
Region
Japan

Condition
Condition Autism spectrum disorder
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the metacognition of individuals with autism spectrum disorder at both behavioral and brain imaging levels.
Basic objectives2 Others
Basic objectives -Others the correlation between the meta-cognitive function and the severity of autism spectrum disorder
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Multi-modality of MRI 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
Device,equipment
Interventions/Control_1 Individuals with autism spectrum disorder
Interventions/Control_2 Healthy controls
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
50 years-old >
Gender Male and Female
Key inclusion criteria Patients
1) Individuals who is diagnosed as autism spectrum disorder based on DSM-IV-TR
2) Individuals who do not have any other neurological or psychiatric disorders
3) Individuals whose IQs are more than 80, and who have capability of informed consent

Healthy controls
1) Individuals who do not have no neurological or psychiatric disorders
2) Individuals whose estimated IQs are more than 80, and who have capability of informed consent
Key exclusion criteria Patients and healthy controls
1) with implanted cardiac pacemaker
2) with surgical aneurysm clips
3) with neurostimulator
4) with implanted pumps
5) with metal fragments in body
6) with tattoos, permanent eyeliner (if ink contains metallic specks)
7) with pregnancy and at risk of becoming pregnant
8) 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 Nobumasa Kato
Organization Showa University Karasuyama Hospital
Division name Medical Institute of Developmental Disabilities Research
Zip code
Address Kitakarasuyama 6-11-11 setagaya-ku, Tokyo
TEL 03-3300-5231
Email katon@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Itahashi
Organization Showa University Karasuyama Hospital
Division name Medical Institute of Developmental Disabilities Research
Zip code
Address Kitakarasuyama 6-11-11 setagaya-ku, Tokyo
TEL 03-3300-5231
Homepage URL http://www10.showa-u.ac.jp/~BIRC/
Email ita3@med.showa-u.ac.jp

Sponsor
Institute Medical Institute of Developmental Disabilities Research, Showa university Karasuyama Hospital
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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
2014 Year 08 Month 06 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
2014 Year 08 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 20 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 08 Month 06 Day
Last modified on
2018 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017182

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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