UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035883 |
|---|---|
| Receipt number | 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 | 2022/02/18 07:29:30 |
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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 | Takashi |
| Middle name | |
| Last name | Hiraoka |
Organization
Kawasaki Medical School
Division name
Dept. of Rehabilitation Medicine
Zip code
7010192
Address
577 Matsushima, Kurashiki, Okayama-pref., Japan.
TEL
086-462-1111
hiraoka@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Hiraoka |
Organization
Kawasaki Medical School
Division name
Dept. of Rehabilitation Medicine
Zip code
7010192
Address
577 Matsushima, Kurashiki, Okayama-pref., Japan.
TEL
086-462-1111
Homepage URL
hiraoka@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
Kawasaki Medical School IRB
Address
577 Matsushima Kurashiki Japan
Tel
086-462-1111
hiraoka@med.kawasaki-m.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
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
27
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 | 02 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 08 | 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 | 15 | Day |
Last modified on
| 2022 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040883
