UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037943 |
|---|---|
| Receipt number | R000043250 |
| Scientific Title | Neural substrates of body perception for children and adults with ASD |
| Date of disclosure of the study information | 2019/09/10 |
| Last modified on | 2019/12/03 07:13:43 |
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Basic information
Public title
Neural substrates of body perception for children and adults with ASD
Acronym
Neural substrates of body perception for children and adults with ASD
Scientific Title
Neural substrates of body perception for children and adults with ASD
Scientific Title:Acronym
Neural substrates of body perception for children and adults with ASD
Region
| Japan |
Condition
Condition
Autism spectrum disorder (ASD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the neural underpinnings of body perception for individuals with ASD
Basic objectives2
Others
Basic objectives -Others
To compare brain activation between individuals with and without ASD while they observe body parts
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fMRI
Key secondary outcomes
AQ, SRS, SP, DCDQ, MABC-2
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
4
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
adults with ASD
Interventions/Control_2
children with ASD
Interventions/Control_3
healthy adults
Interventions/Control_4
healthy children
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 9 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Adults who diagnosed with ASD by DSM-5
2) Adults who give informed consent
Key exclusion criteria
1) Adults who have metal thing in the body
2) Adults who have difficulty in audiovisual function
3) Adults who have difficulty in motor function
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Kosaka |
Organization
University of Fukui
Division name
Department of Neuropsychiatry
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji, Fukui, Japan
TEL
0776-61-8363
hirotaka@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Kosaka |
Organization
University of Fukui
Division name
Department of Neuropsychiatry
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki, Eiheiji, Fukui, Japan
TEL
0776-61-8363
Homepage URL
hirotaka@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
the Meiji Yasuda Mental Health Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Fukui
Address
23-3 Matsuokashimoaizuki, Eiheiji, Fukui, Japan
Tel
0776-61-3111
bsk-ks@ml.u-fukui.ac.jp
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
| 2019 | Year | 09 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 05 | Day |
Last modified on
| 2019 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043250
