UMIN-CTR Clinical Trial

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
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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
Email	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
Email	suganami@keio.jp

Sponsor
Institute	Keio University
Institute
Department

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
Email	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	Preinitiation
Date of protocol fixation	2021 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date	2021 Year 04 Month 01 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	2021 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049092

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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