Protocol summary

Study aim
Comparison of EEG signals before and after visual learning process corresponding to emotions experienced by individuals during the learning, in order to design an emotion recognition system during learning using brain signals.
Design
Quasi-experimental clinical trial, Before-after design, One intervention group with 20 healthy subjects.
Settings and conduct
This study focuses on recognizing emotions involved in the learning process using biological signals, at Tarbiat Modares University of Iran. The procedure: 1. Identifying individuals with visual learning style to participate in the experiments, using a psychological personality questionnaire, 2. EEG signal acquisition from the participants before and during the visual learning process, 3. Evaluating the learning performance of the subjects based on a written test, 4. Assessing emotions experienced by the subjects during the learning process based on self-report questionnaires, 5. Assigning subjects to two groups of with effective learning (good learning with positive emotions according to stage 3 and 4, respectively) and with ineffective learning (poor learning with negative emotions according to stage 3 and 4, respectively), 6. Within-group and between-group comparison of recorded EEG signals before and during the learning process, to design an EEG-based emotion recognition system. In this step, we will focus on statistical analysis and classification methods.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female, aged between 25 to 31 years, healthy individuals, university-graduated or student, visual learning style. Exclusion criteria: History of mental disorders, medication use, visual impairment, hearing impairment.
Intervention groups
Intervention group: A visual learning task, while recording EEG signals.
Main outcome variables
Brain neural activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200212046473N4
Registration date: 2020-06-18, 1399/03/29
Registration timing: retrospective

Last update: 2020-06-18, 1399/03/29
Update count: 0
Registration date
2020-06-18, 1399/03/29
Registrant information
Name
Zeynab Khodakarami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 5080
Email address
z.khodakarami@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
2015-11-22, 1394/09/01
Actual recruitment end date
2015-12-21, 1394/09/30
Trial completion date
2015-12-21, 1394/09/30
Scientific title
EEG-based emotion recognition during visual learning process in healthy females
Public title
Emotion recognition during learning process using brain signals
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 25 to 31 years Healthy individuals University-graduated or student Visual learning style
Exclusion criteria:
History of mental disorders Medication use Visual impairment Hearing impairment
Age
From 25 years old to 31 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Actual sample size reached: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr Bridge, Jalal-Ale-Ahmad
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
IR.TMU.REC.1394.138

Health conditions studied

1

Description of health condition studied
Emotional states experienced during learning
ICD-10 code
R45.89
ICD-10 code description
Other symptoms and signs involving emotional state

Primary outcomes

1

Description
Brain neural activity
Timepoint
Before the intervention at the beginning of the session, During the learning process
Method of measurement
Recording EEG signals

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A visual learning task, while recording EEG signals. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC), along with the golden electrodes, will be used to record EEG signals.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tarbiat Modares University
Full name of responsible person
Zeynab Khodakarami
Street address
Department of Medical Physics, Faculty of Medical Sciences, Tarbiat Modares University, Nasr Bridge, Jalal-Ale-Ahmad
City
Tehran
Province
Tehran
Postal code
14115-331
Phone
+98 21 8288 3821
Email
z.khodakarami@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Yaghoub Fathollahi
Street address
Vice Chancellor for Research and Technology, Tarbiat Modares University, Nasr Bridge, Jalal-Ale-Ahmad
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 2009
Email
res@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Modares Science and Technology Park
Full name of responsible person
Zeynab Khodakarami
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
No. 15, Heyat St., Eshraghi Alley, North Karegar Ave.
City
Tehran
Province
Tehran
Postal code
1411893171
Phone
+98 21 6691 9131
Email
z.khodakarami@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammad Firoozabadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Department of Medical Physics, Faculty of Medical Sciences, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
14115-331
Phone
+98 21 8288 3821
Email
pourmir@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Modares Science and Technology Park
Full name of responsible person
Zeynab Khodakarami
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
No. 15, Heyat St., Eshraghi Alley, North Karegar Ave.
City
Tehran
Province
Tehran
Postal code
1411893171
Phone
+98 21 6691 9131
Email
z.khodakarami@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All participants' data, after anonymization, will be shared through local and international biosignal online databases. The study protocol, statistical analysis map and informed consent can also be shared.
When the data will become available and for how long
Data and documents will be available once the results are published for an unlimited period.
To whom data/document is available
University researchers
Under which criteria data/document could be used
Commitment to mention the source of data and the name of principal investigator for any use, commitment not to use for clinical purposes
From where data/document is obtainable
Correspondence with the representative of principal investigator, Zeynab Khodakarami, with email address: z.khodakarami@gmail.com
What processes are involved for a request to access data/document
Request review by the representative of principal investigator (2 weeks), sharing the application with the principal investigator (2 weeks), final statement by the representative of principal investigator
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