UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035986
Receipt number R000040987
Scientific Title A study of social behavior in developmental disorder using repetitive transcranial magnetic stimulation
Date of disclosure of the study information 2019/03/01
Last modified on 2019/12/19 12:57:55

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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 or person

Institute

Showa University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040987


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name