UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043352 |
|---|---|
| Receipt number | R000049092 |
| Scientific Title | Assessment of Effects of Traumatic Brain Injury on Moral judgment by Third-Party Punishment Task |
| Date of disclosure of the study information | 2021/02/20 |
| Last modified on | 2023/08/23 12:10:41 |
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Basic information
Public title
Assessment of Effects of Traumatic Brain Injury on Moral judgment by Third-Party Punishment Task
Acronym
TBI and Moral Judgement
Scientific Title
Assessment of Effects of Traumatic Brain Injury on Moral judgment by Third-Party Punishment Task
Scientific Title:Acronym
TBI and Moral Judgement
Region
| Japan |
Condition
Condition
Traumatic Brain Injury
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess how traumatic brain injury (TBI) affects our moral judgement by using the third party punishment task (TPP), and to compare the outcome with the healthy subjects.
Basic objectives2
Others
Basic objectives -Others
Some patients with traumatic brain injury display several aspects of change on their characters, among which is their moral judgement. We compare their reaction on the third party punishment task with that of the healthy subjects, and assess the effect of traumatic brain injury on moral judgement
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The outcome of the third party punishment task
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subject who meet all of the following conditions are eligible to participate in this study.
(1) 20 to 80 years old
(2) Subjects with traumatic brain injury due to head injury or organic brain diseases
(3) his/her mother tongue is Japanese
(4) Understand the purpose and content of this study and express written consent to participate in this study based on own will
Subject who meet all the following conditions are eligible to participate in this study as the healthy controls.
(1) 20 to 80 years old
(2) Subjects without traumatic brain injury due to head injury or organic brain diseases
(3) his/her mother tongue is Japanese
(4) Understand the purpose and content of this study and express written consent to participate in this study based on own will
Key exclusion criteria
Subjects with any of the following conditions are excluded from this study.
(1) History of psychotic disorders such as mood disorders, schizophrenia and alcohol / substance use disorders
(2) Subjects who have a life-threatening or unstable physical, brain, or mental illness in clinical diagnosis
(3) Subjects who have symptoms interfering with this research, such as significant memory impairment, intellectual disability or suicidal idea/acts
(4) Others that the Principal Investigator has determined to be inappropriate for this research
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Mimura |
Organization
Keio University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-5363-3971
mimura@a7.keio.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Suganami |
Organization
Keio University Postgraduate School of Medicine
Division name
Department of Neuropsychiatry
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-5363-3971
Homepage URL
suganami@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Clinical and Translational Research Center
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2021 | Year | 02 | Month | 20 | 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
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conduct the third party punishment task by a face to face interview on the patients with traumatic brain injury and healthy subjects, and compare and analyze the outcomes.
Management information
Registered date
| 2021 | Year | 02 | Month | 17 | Day |
Last modified on
| 2023 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049092
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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