UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015269 |
|---|---|
| Receipt number | R000017760 |
| Scientific Title | Neuroimaging study of auditory information processing in autism spectrum disorder |
| Date of disclosure of the study information | 2014/09/29 |
| Last modified on | 2018/03/17 14:34:07 |
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Basic information
Public title
Neuroimaging study of auditory information processing in autism spectrum disorder
Acronym
Neuroimaging study of auditory information processing in ASD
Scientific Title
Neuroimaging study of auditory information processing in autism spectrum disorder
Scientific Title:Acronym
Neuroimaging study of auditory information processing in ASD
Region
| Japan |
Condition
Condition
Individuals with autism spectrum disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the neural basis of auditory information processing in individuals with autism spectrum disorder.
Basic objectives2
Others
Basic objectives -Others
To explore the relationship between the ability of auditory information processing and the severity of autism spectrum disorder.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Multimodal MRI (functional MRI, structural MRI, and diffusion tensor imaging) 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
Normal 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
Individuals with autism spectrum disorder:
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
Normal 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
Individuals with autism spectrum disorder (ASD) and normal 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 (individuals with ASD only)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobumasa Kato |
Organization
Showa University
Division name
Medical Institute of Developmental Disabilities Research
Zip code
Address
6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo
TEL
03-3300-5231
katon@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Itahashi |
Organization
Showa University
Division name
Medical Institute of Developmental Disabilities Research
Zip code
Address
6-11-11 Kita-karasuyama, 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
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 29 | 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 | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | 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
| 2014 | Year | 09 | Month | 27 | Day |
Last modified on
| 2018 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017760
