UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014776 |
|---|---|
| Receipt number | 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 | 2020/02/27 04:24:08 |
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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 | Nobumasa |
| Middle name | |
| Last name | Kato |
Organization
Showa University Karasuyama Hospital
Division name
Medical Institute of Developmental Disabilities Research
Zip code
157-8577
Address
Kitakarasuyama 6-11-11 setagaya-ku, Tokyo
TEL
03-3300-5231
katon@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Itahashi |
Organization
Showa University Karasuyama Hospital
Division name
Medical Institute of Developmental Disabilities Research
Zip code
157-8577
Address
Kitakarasuyama 6-11-11 setagaya-ku, Tokyo
TEL
03-3300-5231
Homepage URL
http://www10.showa-u.ac.jp/~BIRC/
ita3@med.showa-u.ac.jp
Sponsor or person
Institute
Medical Institute of Developmental Disabilities Research, Showa university Karasuyama Hospital
Institute
Department
Personal name
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
Institutional Review Board of Showa University Karasuyama Hospital
Address
6-11-11 Kitakarasuyama,Setagaya-ku,Tokyo,157-8577 Japan
Tel
03-3300-5231
showa-crc@ofc.showa-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
| 2014 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000017182
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000017182
Number of participants that the trial has enrolled
34
Results
We investigated whether adults with autism spectrum disorder (ASD) intentionally suppress memory compared with typically developed adults (TD) using think/ no think task that is categorized into meta-cognition task. Eighteen typically developed adults and 16 adults with autism spectrum disorder participated in this study. The results showed that no difference between ASD and TD about the ability of intentionally suppressing the memory was observed (p = 0.8869).
Results date posted
| 2020 | Year | 02 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
typically developed adults and adults with autism spectrum disorders
Participant flow
After providing voluntarily written informed consent, participants conducted think/ no think task.
Adverse events
no adverse events
Outcome measures
percent correct of Think/no think task
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 11 | Day |
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
| 2020 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017182
