UMIN-CTR Clinical Trial

Basic information
Public title	Elucidation of gaze cognitive and social cognitive characteristics of autism spectrum disorder by magnetoencephalography (MEG) measurement
Acronym	Elucidation of gaze cognitive and social cognitive characteristics of autism spectrum disorder by magnetoencephalography (MEG) measurement
Scientific Title	Elucidation of gaze cognitive and social cognitive characteristics of autism spectrum disorder by magnetoencephalography (MEG) measurement
Scientific Title:Acronym	Elucidation of gaze cognitive and social cognitive characteristics of autism spectrum disorder by magnetoencephalography (MEG) measurement
Region	Japan

Condition
Condition	Autism spectrum disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	One of the causes or signs of social disorders in autism spectrum disorders (ASD) is the impairment of joint attention. In connection with this, functional abnormalities such as superior temporal sulcus (STS), dorsomedial prefrontal cortex (dmPFC), and temporoparietal junction (TPJ) have been pointed out by fMRI studies. However, joint attention is an unconscious and fast reaction that occurs in units of tens to hundreds of milliseconds. With fMRI, which has a time resolution of only a few seconds to a few tens of seconds, it has not been possible to clarify what kind of circuits these brain regions form and synchronize and interlock. Therefore, we perform whole-brain measurement using MEG with a time resolution of 1/1000 second. It reveals how these brain regions form circuits in gaze recognition and processing, how they are synchronized and interlocked, and how they are impaired in ASD patients. This is the purpose of this research.
Basic objectives2	Others
Basic objectives -Others	Pathological studies of autism spectrum disorders by functional brain imaging
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Activity of related brain regions by magnetoencephalography measurement
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Enroll in 30 ASD patients aged 20 years or older with no intellectual disability and borderline intelligence (ie IQ 85 or higher) and 30 neurotypical (TD) groups matched by age, gender, and IQ. For the diagnosis of ASD, the 5th edition (DSM-5) of the Diagnosis and Statistics Manual for Mental Illness is used, and the diagnosis is made with the unanimous agreement of two psychiatrists who have been examined separately. For IQ evaluation, use WAIS-III or WAIS-IV, and enter after confirming that FIQ85 or higher and that there is no problem in language comprehension (VIQ85 or higher).
Key exclusion criteria	In order to exclude the effects of secondary disorders, cases of coexisting mental illness such as schizophrenia and depression are excluded. We do not exclude abnormalities in the developmental disability zone that are often associated with ASD, such as lack of attention / hyperactivity, localized learning disabilities, communal motor disorders, tic disorders, and Tourette's disorders, and are thought to be inherent in the patient.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Atsunori Middle name Last name Sugimoto
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Community Psychiatric Medicine
Zip code	9518510
Address	757, Asahimachi-dori-ichibancho, Chuo-ku, Niigata, Niigata
TEL	0258-227-2213
Email	sugimoto.pedpsy@gmail.com

Public contact
Name of contact person	1st name Atsunori Middle name Last name Sugimoto
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Community Psychiatric Medicine
Zip code	9518510
Address	757, Asahimachi-dori-ichibancho, Chuo-ku, Niigata, Niigata
TEL	0258-227-2213
Homepage URL
Email	sugimoto.pedpsy@gmail.com

Sponsor
Institute	Department of Community Psychiatric Medicine, Niigata University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Niigata University Ethics Review Board
Address	757, Asahimachi-dori-ichibancho, Chuo-ku, Niigata, Niigata
Tel	025-227-2625
Email	sanonao@adm.niigata-u.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	新潟大学大学院医歯学総合研究科地域精神医療学講座(新潟県)、新潟大学大学院医歯学総合研究科精神医学分野(新潟県)、新潟大学医歯学総合病院精神科(新潟県)

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 06 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	21
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	2019 Year 12 Month 19 Day
Date of IRB	2019 Year 12 Month 19 Day
Anticipated trial start date	2019 Year 12 Month 19 Day
Last follow-up date	2022 Year 06 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	MEG measurement during gaze cognitive task by visual stimulus is performed for the subjects in the patient group and the typical development group. Compare the results of both groups and examine the differences in gaze cognitive processing between the two groups.

Management information
Registered date	2022 Year 06 Month 06 Day
Last modified on	2022 Year 06 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054673