UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013436 |
|---|---|
| Receipt number | 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 09:04:55 |
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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
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
yamagata@a6.keio.jp
Sponsor or person
Institute
Showa University School of Medicine, Department of Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015633
