UMIN-CTR Clinical Trial

Basic information
Public title	Neural basis of evaluating the affective impact of remarks on listener based on social communication context in individuals with Autism Spectrum Disorder.
Acronym	Neural basis of inferring the impact of remark in communication on listener in autism.
Scientific Title	Neural basis of evaluating the affective impact of remarks on listener based on social communication context in individuals with Autism Spectrum Disorder.
Scientific Title:Acronym	Neural basis of inferring the impact of remark in communication on listener in autism.
Region	Japan

Condition
Condition	Autism Spectrum Disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the neural basis of evaluating the affective impact of remarks in communication on listener based on relation between speaker and listener.
Basic objectives2	Others
Basic objectives -Others	To reveal the specific brain region related to evaluating the affective impact of remarks in communication on listener based on relation between speaker and listener in adults with autism using functional MRI technique.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Task performance and functional brain image.
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	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Adults with Autism Spectrum Disorder.
Interventions/Control_2	Typically developed adults.
Interventions/Control_3
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	18 years-old <=
Age-upper limit	26 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients 1) Adults who were diagnosed as autism spectrum disorder based on DSM-IV-TR or DSM-5, and confirmed the diagnosis by AQ. 2) Adults who do not have any severe neuropsychiatric disorders and physical illness. 3) Adults whose IQs are above 70, and who can give informed consent. Typical control 1) Adults who do not have any severe neuropsychiatric disorders and physical illness. 2) Adults whose IQs are above 70, and who can give informed consent.
Key exclusion criteria	Adults who has diagnoses as neuropsychiatric disorder and intellectual disorder, who is extreme myopia, who is pregnant, who have metal thing in a surface of a body, who can't control body temperatures adequately and who don't have ability to consent.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yasuyuki Middle name Last name Taki
Organization	Institute of Development, Aging and Cancer, Tohoku University
Division name	Department of Nuclear Medicine and Radiology
Zip code	980-8575
Address	4-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL	022-717-8556
Email	yasuyuki.taki.c7@tohoku.ac.jp

Public contact
Name of contact person	1st name Akiko Middle name Last name Kobayashi
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Nuclear Medicine and Radiology
Zip code	980-8575
Address	4-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL	022-717-3572
Homepage URL
Email	akiko.kobayashi.q6@dc.tohoku.ac.jp

Sponsor
Institute	Institute of Development, Aging and Cancer, Tohoku University
Institute
Department

Funding Source
Organization	Institute of Development, Aging and Cancer, Tohoku University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee Tohoku University Graduate School of Medicine
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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	2016 Year 05 Month 19 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	41
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	No longer recruiting
Date of protocol fixation	2016 Year 05 Month 11 Day
Date of IRB	2016 Year 05 Month 11 Day
Anticipated trial start date	2016 Year 05 Month 19 Day
Last follow-up date	2019 Year 07 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	2016 Year 05 Month 19 Day
Last modified on	2019 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025772