UMIN-CTR Clinical Trial

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
Email	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
Email	hirotaka@u-fukui.ac.jp

Sponsor
Institute	University of Fukui
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043250