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Design of neurofeedback machine framework based on brain signal irregularity to enhance working memory

Protocol summary

Study aim
1- To design a more effective neurofeedback system based on adaptive linear combination of features, 2- To evaluate the effectiveness of the proposed neurofeedback system.
Design
Randomized clinical trial, with control group, two-arm parallel groups, simple random allocation, intervention and control group: each 6 subjects.
Settings and conduct
This study focuses on the development of systems used to enhancement working memory, at Tarbiat Modares University of Iran. The procedure: I. Extraction of features to design a more effective neurofeedback protocol, II. Design and implement of neurofeedback system based on adaptive linear combination of features, III. 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 10 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 student, neurofeedback-novice. Exclusion criteria: Have history of neurological diseases, medication use.
Intervention groups
Intervention group: Neurofeedback based on adaptive linear combination of features. Control group: Conventional neurofeedback. All two groups: Ten training sessions, two sessions per week. With the aim of enhancing second lower Alpha power at Oz channel in two groups, while also decreasing permutation entropy at Fz channel in intervention group.
Main outcome variables
Working memory performance, Brain neural activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200404046931N1
Registration date: 2020-04-09, 1399/01/21
Registration timing: retrospective

Last update: 2020-04-09, 1399/01/21
Update count: 0
Registration date
2020-04-09, 1399/01/21
Registrant information
Name
neda behzadfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3651 7076
Email address
n.behzadfar@pel.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-07-13, 1392/04/22
Expected recruitment end date
2013-11-13, 1392/08/22
Actual recruitment start date
2013-09-23, 1392/07/01
Actual recruitment end date
2014-01-21, 1392/11/01
Trial completion date
2014-03-11, 1392/12/20
Scientific title
Design of neurofeedback machine framework based on brain signal irregularity to enhance working memory
Public title
Design of neurofeedback machine framework to enhance working memory
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy Have normal or corrected-to-normal vision University student Neurofeedback-novice.
Exclusion criteria:
Have history of neurological diseases 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: 12
Actual sample size reached: 12
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
2013-07-13, 1392/04/22
Ethics committee reference number
IR.TMU.REC.2005/D52, Dated: 13-07-2013

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, after the intervention in the posttest session
Method of measurement
Cognitive assessment of static and dynamic working memory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Neurofeedback based on adaptive linear combination of features, through self-regulation of features' coefficients during training. With the aim of enhancing EEG second lower Alpha power at Oz channel and decreasing permutation entropy at Fz channel to improve memory, 10 training sessions including three ten-minutes training trials. Two sessions a week. 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: Conventional neurofeedback. With the aim of enhancing EEG second lower Alpha power at Oz channel to improve memory. 10 training sessions including three ten-minutes training trials. Two sessions a week. 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
Neda Behzadfar
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
behzadfar_neda@yahoo.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
City
Tehran
Province
Tehran
Postal code
14115-331
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
Islamic Azad University, Najafabad Branch
Full name of responsible person
Neda Behzadfar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
University Sq., Najafabad, Isfahan, Iran
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2929
Email
behzadfar_neda@yahoo.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
Islamic Azad University, Najafabad Branch
Full name of responsible person
Neda Behzadfar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
University Sq., Najafabad, Isfahan, Iran
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Phone
+98 31 4229 2929
Email
behzadfar_neda@yahoo.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, Neda Behzadfar, with email address: behzadfar_neda@yahoo.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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