Evaluation of connectivity features between cardiac and brain signals in emotion recognition
Design
Quasi-experimental clinical trial, Before-after design, One intervention group with 6 healthy subjects
Settings and conduct
This study is carried out on emotion recognition using the heart-brain connectivity at Tarbiat Modares University of Iran. The procedure:
1. Gathering validated emotional clips
2. Pilot signal acquisition
3. Assessment of pilot signals before the main acquisition
4. Forehead and cardiac biosignal acquisition from the participants before and after emotional intervention
5. Biosignal analysis and emotion recognition system design
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female, Healthy, University student, Aged between 24 to 30 years, Normal or corrected-to-normal vision. Exclusion criteria: History of neurological diseases, Medication use, Unpleasant mental effect by emotional clips, Fasting
Intervention groups
Intervention group: Displaying six emotional video clips to participants in order to induce six basic emotions, while recording cardiac and forehead bioelectric signals.
Main outcome variables
Brain neural activity, Cardiac neural activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200410047015N1
Registration date:2020-04-27, 1399/02/08
Registration timing:retrospective
Last update:2020-04-27, 1399/02/08
Update count:0
Registration date
2020-04-27, 1399/02/08
Registrant information
Name
Vesal Moaiyed
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 6303
Email address
vesal.moaiyed@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-31, 1396/03/10
Expected recruitment end date
2017-06-10, 1396/03/20
Actual recruitment start date
2017-05-31, 1396/03/10
Actual recruitment end date
2017-06-10, 1396/03/20
Trial completion date
2017-06-10, 1396/03/20
Scientific title
Emotion recognition using connectivity features between cardiac and forehead biosignals
Public title
Emotion recognition using heart-brain connectivity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female
Aged between 24 to 30 years
University student
Healthy
Normal or corrected-to-normal vision
Exclusion criteria:
History of neurological diseases
Medication use
Unpleasant mental effect by emotional clips
Fasting
Age
From 24 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
6
Actual sample size reached:
6
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
2017-01-18, 1395/10/29
Ethics committee reference number
IR.TMU.REC.1395.497
Health conditions studied
1
Description of health condition studied
Healthy individuals
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Brain neural activity
Timepoint
Before the intervention, While displaying the neutral video, While displaying the emotional videos
Method of measurement
Acquisition of forehead bioelectric signals
2
Description
Cardiac neural activity
Timepoint
Before the intervention, While displaying the neutral video, While displaying the emotional videos
Method of measurement
ECG acquisition
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Displaying six emotional video clips to participants to induce six basic emotions (Anger, Disgust, Fear, joy, Sadness, Surprise), while recording cardiac and forehead bioelectric signals. Also, a neutral video was displayed before each emotional video.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tarbiat Modares University
Full name of responsible person
Vesal Moaiyed
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
v.moaiyed@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
Tarbiat Modares University
Full name of responsible person
Vesal Moaiyed
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
Bioelectromagnetics Laboratory, Department of Medical Physics, Faculty of Medical Sciences, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
14115-331
Phone
+98 21 8288 3839
Email
v.moaiyed@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
Tarbiat Modares University
Full name of responsible person
Vesal Moaiyed
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
Bioelectromagnetics Laboratory, Department of Medical Physics, Faculty of Medical Sciences, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
14115-331
Phone
+98 21 8288 3839
Email
v.moaiyed@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 for an unlimited period once the results are published.
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, Vesal Moaiyed, with email address: v.moaiyed@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