UMIN-ICDR Clinical Trial

Basic information
Public title	Neurocognitive study of empathic embarrassment
Acronym	Neurocognitive study of empathic embarrassment
Scientific Title	Neurocognitive study of empathic embarrassment
Scientific Title:Acronym	Neurocognitive study of empathic embarrassment
Region	Japan

Condition
Condition	adults
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to examine the neurocognitive mechanism underlying empathic embarrassment and social anxiety. In this endeavor, we investigate the relationship between the strength of brain activity during empathic embarrassment task and psychological scores of our participants. In particular, we measure the features of empathic skill, self-awareness, embarrassment, and social anxiety sensitivities as well as cognitive flexibility ability by using the questionnaires of Interpersonal Reactivity Index (IRI), Toronto Alexithymia Scale (TAS), Taijin Kyofusho scale (TKS), and Wisconsin Card Sorting Test (WCST). We hypothesize that social anxiety level (TKS) correlates positively with affective empathy but correlates negatively with cognitive empathy. To test this prediction further, we extract fMRI signal strength from the anterior insula, anterior cingulate cortex, and amygdala for the affective empathy contrast, and the medial prefrontal cortex, posterior superior temporal sulcus, and temporoparietal junction for the cognitive empathy contrast and investigate their association with the TKS score.
Basic objectives2	Others
Basic objectives -Others	We investigate the individual differences in brain function.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We evaluate the relationship between the features of brain imaging data and personality characteristics of the participants (i.e., embarrassment, empathy, and social anxiety levels) using functional MRI and psychological tests.
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
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Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	Aged 18-59 years-old Capability of informed consent
Key exclusion criteria	1) Subjects who are contraindicated for the use of MRI (e.g., implanted cardiac pacemaker, surgical aneurysm clips) 2) History (or possibility) of pregnancy. 3) Subjects who are judged as unsuitable for participation in this study
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Hidehiko Middle name Last name Takahashi
Organization	Kyoto University
Division name	Department of Psychiatry, Graduate School of Medicine
Zip code	606-8507
Address	54 Shogoin-Kawara-cho Sakyo-ku
TEL	075-753-7531
Email	hidehiko@kuhp.kyoto-u.

Public contact
Name of contact person	1st name Shisei Middle name Last name Tei
Organization	Kyoto University
Division name	Department of Psychiatry, Graduate School of Medicine
Zip code	606-8507
Address	54 Shogoin-Kawara-cho Sakyo-ku
TEL	075-751-4947
Homepage URL
Email	showa.m3@gmail.com

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	MEXT(Japan)
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	Committee on Medical Ethics of Kyoto University
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel	075-753-7531
Email	showa.m3@gmail.com

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 11 Month 02 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	23
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	2013 Year 11 Month 06 Day
Date of IRB	2013 Year 12 Month 06 Day
Anticipated trial start date	2014 Year 05 Month 29 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study was approved by the Committee on Medical Ethics of Kyoto University under the title of "Neurocognitive study of empathy associated with social emotion" and preregistered in Kyoto University (Japan; ID: E1924, issued on January 30, 2014), in National Science Foundation (United States; ID: 2011122786, issued on June 6, 2013), and in Japan Society for the Promotion of Science (Japan; ID: GR13005) that included the pre-analytical plan.

Management information
Registered date	2019 Year 11 Month 02 Day
Last modified on	2020 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043844

Research Plan
Registered date	File name
2019/12/31	TKS_data_processing_pipeline_ori.txt

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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