UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024286 |
|---|---|
| Receipt number | R000026696 |
| Scientific Title | Neural mechanism of voice processing in autism spectrum disorder and schizophrenia |
| Date of disclosure of the study information | 2016/10/04 |
| Last modified on | 2019/10/29 10:04:58 |
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Basic information
Public title
Neural mechanism of voice processing in autism spectrum disorder and schizophrenia
Acronym
Voice processing in ASD and schizophrenia
Scientific Title
Neural mechanism of voice processing in autism spectrum disorder and schizophrenia
Scientific Title:Acronym
Voice processing in ASD and schizophrenia
Region
| Japan |
Condition
Condition
Autism spectrum disorder
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify neural network in processing of human voice in ASD and Schizophrenia by using fMRI
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fMRI, 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
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Individuals with autism spectrum disorder
Interventions/Control_2
individuals with schizophrenia
Interventions/Control_3
Normal controls
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-V
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
Individuals with schizophrenia:
1) Individuals who is diagnosed as schizophrenia based on DSM-V
2) Individuals who do not have any other neurological or psychiatric disorders
3) Individuals 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
90
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 | Rieko Okada |
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
rokada@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 Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
| 2016 | Year | 10 | Month | 04 | 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
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 04 | Day |
Last modified on
| 2019 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026696
| Research Plan | |
|---|---|
| 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 |
