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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013436
Receipt No. R000015633
Scientific Title Neuroimaging study in autism spectrum disorder
Date of disclosure of the study information 2014/04/01
Last modified on 2016/11/12

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Basic information
Public title Neuroimaging study in autism spectrum disorder
Acronym Neuroimaging study in ASD
Scientific Title Neuroimaging study in autism spectrum disorder
Scientific Title:Acronym Neuroimaging study in ASD
Region
Japan

Condition
Condition Individuals with autism spectrum disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Autism is a neurobiological condition with a strong genetic component characterized by impairments in social interaction and communication as well as restricted, repetitive, and stereotyped patterns of behavior, interests, and activities. Family studies
have indicated that concordance rates for autism are 2% to 6% for siblings and dizygotic twins and approximately 60% for monozygotic twins. Still, most siblings of probands with autism do not have any symptoms of autism despite sharing, on average, 50% of their genes and many environmental influences with their siblings with autism. Furthermore, previous studies have suggested that individuals with autism share some aspects of brain structure and function as well as behavioral and immune profiles with their siblings who do not have autism. Therefore, we sought to investigate the similarity and difference of brain anatomy and function among individuals with high-functioning autism spectrum disorder and their siblings to reveal the neurobiological and genetic substrates in high-functioning autism spectrum disorder.
Basic objectives2 Others
Basic objectives -Others To detect the neurobiological substrates in autism spectrum disorder.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Voxel-based Morphometry (VBM)
2. Diffusion Tensor Imaging (DTI)
3. Free Surfer
4. Functional MRI (fMRI)
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 Siblings of autism spectrum disorder
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

Not applicable
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Participants diagnosed as an autism spectrum disorder recruited from Showa university karasuyama hospital, their same-sex unaffected siblings, and healthy controls
Key exclusion criteria Participants have any other neurological or psychiatric disorders
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Osamu Takashio
Organization Showa University School of Medicine
Division name Department of Psychiatry
Zip code
Address 6-11-11 Kita-Karasuyama, Setagaya-Ku, Tokyo, Japan
TEL 03-3300-5231
Email takashio@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Bun Yamagata
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3829
Homepage URL
Email yamagata@a6.keio.jp

Sponsor
Institute Showa University School of Medicine, Department of Psychiatry
Institute
Department

Funding Source
Organization Grant-in-Aid forYoung Scientists (B)
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
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 昭和大学附属烏山病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 04 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
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 Open public recruiting
Date of protocol fixation
2014 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 05 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 03 Month 17 Day
Last modified on
2016 Year 11 Month 12 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015633

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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