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Design and Implement of Second-Generation Neurofeedback System Based on User's Visual Attention, and Evaluate its Efficacy in Memory Enhancement

Protocol summary

Study aim
Develop the next generation of neurofeedback systems with more efficacy and robustness
Design
Randomized clinical trial, with control group, four-arm parallel groups, simple random allocation, intervention group I,II = each 10 subjects, control group I,II = each 10 subjects.
Settings and conduct
This study focuses on the development of systems used to treat mental disorders and for mind empowering, at Tarbiat Modares University of Iran. The procedure: I. Design and implement of visual attention-based neurofeedback system with two novel training protocols, II. Evaluate the system efficacy in memory enhancement compared with the conventional neurofeedback systems, including 1. Assessing static and dynamic working memory performance and recording baseline EEG in pretest session, 2. Conducting six neurofeedback training sessions, 3. Assessing static and dynamic working memory performance and recording baseline EEG in posttest session, 4. Evaluating both the results of working memory tests and EEG signals of pretest, posttest and training sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female, aged between 20 to 35 years, healthy, have normal or corrected-to-normal vision, university-graduated or student, neurofeedback-novice. Exclusion criteria: Have history of neurological diseases, medication use.
Intervention groups
Intervention group I: Visual attention-based neurofeedback with effective visual stimulus. Control group I: Conventional neurofeedback. Intervention group II: Visual attention-based neurofeedback with attentional capture mechanism. Control group II: Conventional neurofeedback by monitoring user's visual attention without attentional capture mechanism. All four groups: with the aim of enhancing EEG Alpha power at Oz channel, six 30 minutes training sessions over two weeks.
Main outcome variables
Working memory performance, brain neural activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200212046473N1
Registration date: 2020-03-24, 1399/01/05
Registration timing: retrospective

Last update: 2020-03-24, 1399/01/05
Update count: 0
Registration date
2020-03-24, 1399/01/05
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
2017-03-21, 1396/01/01
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2017-09-21, 1396/06/30
Trial completion date
2017-09-21, 1396/06/30
Scientific title
Design and Implement of Second-Generation Neurofeedback System Based on User's Visual Attention, and Evaluate its Efficacy in Memory Enhancement
Public title
Design and implement of Visual Attention-Based Neurofeedback System
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 20 to 35 years Healthy Have normal or corrected-to-normal vision University-graduated or student Neurofeedback-novice
Exclusion criteria:
Have history of neurological diseases (e.g. migraine or epilepsy) Medication use
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are selected by random sampling from the community of healthy individuals. After meeting the inclusion and exclusion criteria of the study, they will be assigned by simple randomization method using a random number table into groups of study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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.1394.164

Health conditions studied

1

Description of health condition studied
Healthy individuals
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Working memory performance
Timepoint
Before the intervention in the pretest session, after the intervention in the posttest session
Method of measurement
Cognitive assessment of static and dynamic working memory

2

Description
Brain neural activity
Timepoint
Before the intervention in the pretest session, during the intervention within neurofeedback training sessions, after the intervention in the posttest session
Method of measurement
Recording EEG signals

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group I: Visual attention-based neurofeedback with effective visual stimulus. With the aim of enhancing EEG Alpha power at Oz channel to improve memory, six 30 minutes training sessions over two weeks. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC) with the software developed in this study will be used.
Category
Rehabilitation

2

Description
Control group I: Conventional neurofeedback without monitoring user's visual attention. With the aim of enhancing EEG Alpha power at Oz channel to improve memory, six 30 minutes training sessions over two weeks. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC) with the software developed in this study will be used.
Category
Rehabilitation

3

Description
Intervention group II: Visual attention-based neurofeedback with attentional capture mechanism. With the aim of enhancing EEG Alpha power at Oz channel to improve memory, six 30 minutes training sessions over two weeks. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC) with the software developed in this study will be used.
Category
Rehabilitation

4

Description
Control group II: Conventional neurofeedback by monitoring user's visual attention without attentional capture mechanism. With the aim of enhancing EEG Alpha power at Oz channel to improve memory, six 30 minutes training sessions over two weeks. The device FlexComp Infiniti (Thought Technology Ltd, Montreal, QC) with the software developed in this study will be used.
Category
Rehabilitation

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
Email
z.khodakarami@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Cognitive Sciences and Technologies Council
Full name of responsible person
Majid Nili Ahmadabadi
Street address
No. 35, CSTC Building, Alvand St., Argentina Sq.
City
Tehran
Province
Tehran
Postal code
1516636313
Phone
+98 21 8819 4956
Email
info@cogc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cognitive Sciences and Technologies Council
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Zeynab Khodakarami
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
Biomedical Signal Processing Lab., Faculty of Engineering, Shahed University, Opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
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
Shahed University
Full name of responsible person
Zeynab Khodakarami
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
Biomedical Signal Processing Lab., Faculty of Engineering, Shahed University, Opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
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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