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Brain interaction of task-contents and task-irrelevant emotional distractor in working memory and it’s modulation by voluntary respiration

Status Approved

First Submitted Date

2018/05/03
Registered Date

2018/05/18
Last Updated Date

2018/05/17

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002882
Unique Protocol ID	KHSIRB 2017-002
Public/Brief Title	Brain interaction of task-contents and task-irrelevant emotional distractor in working memory and it’s modulation by voluntary respiration
Scientific Title	Brain interaction of task-contents and task-irrelevant emotional distractor in working memory and it’s modulation by voluntary respiration
Acronym	BMW
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KHSIRB-17-002
Approval Date	2017-02-13
Institutional Review Board Name	Kyung Hee University Institutional Review Board
Institutional Review Board Address	1732, Deogyeong-daero, Giheung-gu, Yongin-si, Gyeonggi-do
Institutional Review Board Telephone	031-201-3536
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Kyungmo Park
Title	Professor
Telephone	+82-31-201-2979
Affiliation	Kyung Hee University
Address	Room 705, Electronic and information building, Kyung Hee University, Seocheondong, Giheunggu, Yonginsi, Gyunggido
Contact Person for Public Queries
Name	Seulgi Eun
Title	Researcher
Telephone	+82-31-201-2757
Affiliation	Kyung Hee University
Address	Room 712, Electronic and information building, Kyung Hee University, Seocheondong, Giheunggu, Yonginsi, Gyunggido
Contact Person for Updating Information
Name	Seulgi Eun
Title	Researcher
Telephone	+82-31-201-2757
Affiliation	Kyung Hee University
Address	Room 712, Electronic and information building, Kyung Hee University, Seocheondong, Giheunggu, Yonginsi, Gyunggido

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2017-03-08 Actual
Target Number of Participant	32
Primary Completion Date	2017-03-08 , Actual
Study Completion Date	2017-07-21 , Actual
Name of Study	Kyung Hee University
Recruitment Status	Completed
Date of First Enrollment	2017-03-08 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Korea Institute of Oriental Medicine
Organization Type	Others
Project ID	K17052

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyung Hee University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	1. Objective Understanding the correlation in the brain connection by the type of information which is handled in the emotional working memory process through working memory task 2. Hypothesis 1st: Emotional working memory process which handled with neutral and emotional information are differently influenced by emotional distracters. 2nd: Task performance(accuracy rate and reaction time) and brain functional connection are changed by voluntary respiration during the emotional working memory process influenced by emotional distracters 3. Background Working memory is one of the human memory systems and is closely associated with individual cognitive abilities. Working memory is affected by distracters when it remembered, stored temporarily, processed, and recalled the information. In this study, we conducted working memory task which distinguish the face and emotion from the neutral and emotional face by participants. This is an experiment that enables us to objectively quantify the interference caused by emotional stimuli in cognitive tasks that often occur in social interactions. We also would like to see how emotional interference stimuli change brain functional connections depending on the type of information, both during the process of storing and recalling information. In addition, methods of breathing are differently affect on behavior and cognitive function. Therefore, we investigate the effects of voluntary respiration control on cognitive function by emotional interference stimuli. 4. Paradigm Our experiment started with 30 minutes of training session. The training session includes explaining all the different types of task to be performed, training breathing techniques and giving brief guidelines on safety measures of fMRI. All the tasks were performed while the subjects are inside the scanner. The experimental paradigm has 5 tasks of events. Face identification task (IC), emotion identification task (EC), face identification with emotional distraction (ID), emotion identification with emotional distraction (ED) and emotion identification with controlled (voluntary) respiration task (RID). The pictures we used for the tasks were based on international affective pictures system (IAPS) and NimStim stimulus set. Each working memory task (event) had 18 trials in a given time of 9 minutes. Depending on the type of task, the study participants can memorize characters or emotions from shown image on the screen which include faces of three people. Then, after 14 seconds, when probe image which contains one person's face (this person might be shown before or not) appears, participants have to answer (push the O/X button) whether it (face/emotion) has been shown or not. All the subjects were given the tasks a pseudo-randomized order without RID task. Instructions were given to the subjects at the beginning and end of each task to avoid confusion. The experiment is based on cross-over study and for this matter we have divided the subjects on two groups. The tasks for the group are randomly assigned which means one group has to RID task while increasing their inspiration length and the other group will do the task increasing their expiration length. The need for this task is to investigate if respiration can modulate working memory performance.

Study Summary Information

Lay Summary

1. Objective
Understanding the correlation in the brain connection by the type of information which is handled in the emotional working memory process through working memory task

2. Hypothesis
1st: Emotional working memory process which handled with neutral and emotional information are differently influenced by emotional distracters.
2nd: Task performance(accuracy rate and reaction time) and brain functional connection are changed by voluntary respiration during the emotional working memory process influenced by emotional distracters

3. Background
Working memory is one of the human memory systems and is closely associated with individual cognitive abilities. Working memory is affected by distracters when it remembered, stored temporarily, processed, and recalled the information. In this study, we conducted working memory task which distinguish the face and emotion from the neutral and emotional face by participants. This is an experiment that enables us to objectively quantify the interference caused by emotional stimuli in cognitive tasks that often occur in social interactions. We also would like to see how emotional interference stimuli change brain functional connections depending on the type of information, both during the process of storing and recalling information. In addition, methods of breathing are differently affect on behavior and cognitive function. Therefore, we investigate the effects of voluntary respiration control on cognitive function by emotional interference stimuli.

4. Paradigm
Our experiment started with 30 minutes of training session. The training session includes explaining all the different types of task to be performed, training breathing techniques and giving brief guidelines on safety measures of fMRI. All the tasks were performed while the subjects are inside the scanner. The experimental paradigm has 5 tasks of events. Face identification task (IC), emotion identification task (EC), face identification with emotional distraction (ID), emotion identification with emotional distraction (ED) and emotion identification with controlled (voluntary) respiration task (RID). The pictures we used for the tasks were based on international affective pictures system (IAPS) and NimStim stimulus set. Each working memory task (event) had 18 trials in a given time of 9 minutes.

Depending on the type of task, the study participants can memorize characters or emotions from shown image on the screen which include faces of three people. Then, after 14 seconds, when probe image which contains one person&#39;s face (this person might be shown before or not) appears, participants have to answer (push the O/X button) whether it (face/emotion) has been shown or not.

All the subjects were given the tasks a pseudo-randomized order without RID task. Instructions were given to the subjects at the beginning and end of each task to avoid confusion. The experiment is based on cross-over study and for this matter we have divided the subjects on two groups. The tasks for the group are randomly assigned which means one group has to RID task while increasing their inspiration length and the other group will do the task increasing their expiration length. The need for this task is to investigate if respiration can modulate working memory performance.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-crossover
Time Perspective	Cross-sectional
Target Number of Participant	32
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label Observation Group 1
Cohort/ Group 1	Cohort/Group Description The experimental paradigm includes five kinds of working memory tasks: face identification task (IC), emotion identification task (EC), face identification with emotional distraction (ID), emotion identification with emotional distraction (ED) and emotion identification with volitional respiration task (RID). Subjects in this group perform those working memory tasks (IC, ID, EC, ED) in randomized order. After performing those four tasks, they proceed RID task using long exhalation. Depending on the tasks, participants have to memorize faces or emotions from shown images on the screen which include faces of three people. Then, after 14 seconds, when probe image which contains one person's face (this person might be shown before or not) appears, participants have to answer (push the O/X button) whether it (face/emotion) has been shown or not.
Cohort/ Group 2	Cohort/Group Label Observation Group 2
Cohort/ Group 2	Cohort/Group Description The experimental paradigm includes five kinds of working memory tasks: face identification task (IC), emotion identification task (EC), face identification with emotional distraction (ID), emotion identification with emotional distraction (ED) and emotion identification with volitional respiration task (RID). Subjects in this group perform those working memory tasks (IC, ID, EC, ED) in randomized order. After performing those four tasks, they proceed RID task using long inhalation. Depending on the tasks, participants have to memorize faces or emotions from shown images on the screen which include faces of three people. Then, after 14 seconds, when probe image which contains one person's face (this person might be shown before or not) appears, participants have to answer (push the O/X button) whether it (face/emotion) has been shown or not.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Participants are 18~33 years-old native Koreans, healthy, right-handed female.
Sampling Method	Quota sampling (non-probabilistic version of stratified sampling) of 18~33 year-old healthy people who are residents in the Suwon
Condition(s)/Problem(s)	Not Applicable-Etc
Rare Disease	No
Inclusion Criteria	Gender Female
	Age 18Year~33Year
	Description Participants : - who are healthy females in age range between 18 and 33 years old - who can understand, respond to the content of the questionnaire and agree to participate in the study and sign a written informed consent
Exclusion Criteria	Participants : - who are suspected of having phychical disoreder such as delirium, dementia, amnesia or other cognitive, mood, anxiety disorder -who have respiratory disease or are difficult to breathe with nose while lying -who are members of this research institute (Department of Biomedical Engineering, Kyung Hee University) -who have discomfort with arms because of disorder or injury -who are illiteracy or hard to discern the monitor with naked eye -who are pregnant or nursing -who are unsuitable for MRI scanning criteria -who are participated in another experiment in recent 3 months -who are incompetent, quasi-incompetent, feeble-minded
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Brain activity in working memory and emotion related area and functional brain connectivity changes
Timepoint	During performing the task
Secondary Outcome(s) 1
Outcome	Accuracy and reaction time
Timepoint	During performing the task
Secondary Outcome(s) 2
Outcome	Questionnaires contained psychological and emotional factors
Timepoint	Before performing the task
Secondary Outcome(s) 3
Outcome	Heart rate change and skin conductance response
Timepoint	During performing the task
Secondary Outcome(s) 4
Outcome	GPA
Timepoint	Before performing the task

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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