UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038477 |
|---|---|
| Receipt number | R000043844 |
| Scientific Title | Neurocognitive study of empathic embarrassment |
| Date of disclosure of the study information | 2019/11/02 |
| Last modified on | 2020/03/26 13:32:23 |
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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
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
| 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
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
showa.m3@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_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 |
