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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035883
Receipt No. R000040883
Scientific Title Elucidation of brain functional basis behind problem behavior in patients with social behavior disorder and clinical application.
Date of disclosure of the study information 2019/03/11
Last modified on 2019/02/15

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Basic information
Public title Elucidation of brain functional basis behind problem behavior in patients with social behavior disorder and clinical application.
Acronym Investigation of social behavior disorder and clinical application
Scientific Title Elucidation of brain functional basis behind problem behavior in patients with social behavior disorder and clinical application.
Scientific Title:Acronym Investigation of social behavior disorder and clinical application
Region
Japan

Condition
Condition patients with social behavior disorder
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the brain function basis behind the problem behaviors in patients with social behavior disorder and to link them to clinical applications.
Basic objectives2 Others
Basic objectives -Others To elucidate the brain function basis behind the problem behaviors in patients with social behavior disorder and to link them to clinical applications.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Comparison between healthy adults and patients in default mode network
Key secondary outcomes Changes in social participation rate of patients with social behavior disorder.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Acquire fMRI data from healthy adult volunteers.
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
16 years-old <=
Age-upper limit
64 years-old >=
Gender Male and Female
Key inclusion criteria Patients with social behavior disorder (expert outpatient clinic) and healthy adults (able to participate in society)
Key exclusion criteria For healthy adults, exclude those not participating in society.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Hiraoka
Organization Kawasaki Medical School
Division name Dept. of Rehabilitation Medicine
Zip code
Address 577 Matsushima, Kurashiki, Okayama-pref., Japan.
TEL 086-462-1111
Email hiraoka@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Hiraoka
Organization Kawasaki Medical School
Division name Dept. of Rehabilitation Medicine
Zip code
Address 577 Matsushima, Kurashiki, Okayama-pref., Japan.
TEL 086-462-1111
Homepage URL
Email hiraoka@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Ministry of education
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
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 11 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 Preinitiation
Date of protocol fixation
2019 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 12 Day
Last follow-up date
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 15 Day
Last modified on
2019 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040883

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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