UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006443 |
|---|---|
| Receipt number | R000007231 |
| Scientific Title | Imageability in adults with autism spectrum disorders: a functional MRI study |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2014/03/31 18:02:12 |
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Basic information
Public title
Imageability in adults with autism spectrum disorders: a functional MRI study
Acronym
Imageability in adults with autism spectrum disorders: a functional MRI study
Scientific Title
Imageability in adults with autism spectrum disorders: a functional MRI study
Scientific Title:Acronym
Imageability in adults with autism spectrum disorders: a functional MRI study
Region
| Japan |
Condition
Condition
Autism spectrum disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate disability of image in adults with autism spectrum disorder by using fMRI.
Basic objectives2
Others
Basic objectives -Others
neuroimaging
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate brain mechanisms of imagery in autism spectrum disorder
Key secondary outcomes
To study reactions of brain mechanisms and mood to ostracism in autism spectrum disorders
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Key inclusion criteria
1. Autism spectrum disorder
1-1 Outpatients in Department of Psychiatry of Hiroshima University Hospital and Matsuda Hospital
1-2 Autism and Asperger syndrome diagnosed based on DSM-4
1-3 Patients given informed consent
1-4 Patients who have over 80 full IQ by WAIS-3
1-5 right handed
1-6 Patients who have no inner steel
2.Contol
2-1Individuals given informed consent
2-2 right handed
2-3 Individuals who have no inner steel
Key exclusion criteria
1. Autism spectrum disorder
1-1.Patients who are in too severe mental states to understand the content of this study
1-2. Patients who have too severe physical disease to participate this study
1-3. Patients taking tranquiraizer
2. Control
2-1 Individuals with first degree relative suffering from psychiatric disease
2-2. Individuals with psychiatric and neurological past history
2-3. Individuals who have under 80 full IQ by WAIS-3
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeto Yamawaki |
Organization
Hiroshima University Hospital
Division name
Department of psychiatry
Zip code
Address
Kasumi 1-2-3,Minami-ku,Hiroshima City
TEL
082-257-5208
d094719@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuko Hayashi |
Organization
Graduate School of Biomedical Sciences Hiroshima University
Division name
Department of psychiatry and Neurosciences
Zip code
Address
Kasumi 1-2-3,Minami-ku,Hiroshima City
TEL
082-257-5208
Homepage URL
D094719@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Suiseikai Matsuda Hospital
Suiseikai Kajikawa Hospital
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 01 | 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
Activity of helthy subjects was higher than patients with autism spectrum disorder in left middle frontal gyrus and left fusiform gyrus during visual image.
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
| 2011 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
The comparison of imageability of kanji words was examined for helthy subjects with patients with autism spectrum disorder.
Management information
Registered date
| 2011 | Year | 09 | Month | 29 | Day |
Last modified on
| 2014 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007231
| Research Plan | |
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| 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 |
