UMIN-CTR Clinical Trial

Basic information
Public title	A study of social behavior in developmental disorder using repetitive transcranial magnetic stimulation
Acronym	A study of social behavior in developmental disorder using repetitive transcranial magnetic stimulation
Scientific Title	A study of social behavior in developmental disorder using repetitive transcranial magnetic stimulation
Scientific Title:Acronym	A study of social behavior in developmental disorder using repetitive transcranial magnetic stimulation
Region	Japan

Condition
Condition	Healthy subjects, individuals with ASD
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the role of rTPJ in neural mechanisms of social behavior.
Basic objectives2	Others
Basic objectives -Others	To investigate the individual differences in social behavior.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Decision-making task
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	rTMS on rTPJ (inhibition, sham)
Interventions/Control_2	rTMS on rTPJ (inhibition, sham)
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	50 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy group 1) Aged 20-49 years-old 2) No serious psychiatric disorders or medical illness. 3) Capability of informed consent ASD group 1) Subjects who had received a clinical diagnosis of ASD in outpatient units of the Showa University Karasuyama Hospital. 2) Aged 20-49 years-old 3) No serious comorbid psychiatric disorders or medical illness. 4) Capability of informed consent
Key exclusion criteria	1) Subjects who are contraindicated for the use of MRI and TMS (e.g., implanted cardiac pacemaker, surgical aneurysm clips) 2) History of epilepsy, pregnancy, treatment with medication that can lower the seizure threshold. 3) Subjects who are judged as unsuitable for participation in this study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Motoaki Nakamura
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Zip code
Address	6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo, Japan
TEL	03-5315-9357
Email	mri.kenkyu@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Junya Fujino
Organization	Showa University
Division name	Medical Institute of Developmental Disabilities Research
Zip code
Address	6-11-11 Kita-karasuyama, Setagaya-ku, Tokyo, Japan
TEL	03-5315-9357
Homepage URL
Email	fujinoj@med.showa-u.ac.jp

Sponsor
Institute	Showa University
Institute
Department

Funding Source
Organization	Magnetic Health Science 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
Address
Tel
Email

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 03 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	Enrolling by invitation
Date of protocol fixation	2019 Year 02 Month 23 Day
Date of IRB	2018 Year 08 Month 20 Day
Anticipated trial start date	2019 Year 03 Month 05 Day
Last follow-up date	2020 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 02 Month 23 Day
Last modified on	2019 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040987