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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024286
Receipt No. 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 2017/04/06

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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
Email 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
Email rokada@med.showa-u.ac.jp

Sponsor
Institute Medical Institute of Developmental Disabilities Research, Showa University
Institute
Department

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
Email

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
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 30 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
2016 Year 10 Month 04 Day
Last modified on
2017 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026696

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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