UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| 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 | 2020/02/27 (Ver. 6) |
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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 | |
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| Condition | |||
| Condition | Autism spectrum disorder | ||
| Classification by specialty |
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| 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 |
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| Interventions/Control_1 | Individuals with autism spectrum disorder | |
| Interventions/Control_2 | Healthy controls | |
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| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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 |
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| 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) |
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| Target sample size | 40 | |||
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| Name of lead principal investigator |
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| 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 |
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| 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 | |
| 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 | 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 | |
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| Date of disclosure of the study information |
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| 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). |
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| Results date posted |
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | typically developed adults and adults with autism spectrum disorders |
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| Participant flow | After providing voluntarily written informed consent, participants conducted think/ no think task. |
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| Adverse events | no adverse events |
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| Outcome measures | percent correct of Think/no think task |
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| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017182 |
