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
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
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
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
