Study of the treatment process of children with attention deficit hyperactivity disorder.
Dynamic difficulty Adjustment of the game based on the performance and Attention of the participant.
Neurofeedback-based game performance evaluation in treatment compared to normal neurofeedback.
Design
Clinical trials with a controlled group, randomized, single blinded
Settings and conduct
After finding children with attention deficit hyperactivity disorder and obtaining consent from their parents, they enter the intervention.
These children receive intervention 10 Session, 3 times a week for 40 minutes.
Before the intervention and after the intervention, they receive baseline signal.
These intervention sessions take place at the Isfahan University Computer Games Center.
Data collection tools included: questionnaire, cognitive test and Electroencephalogram recorder.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with Attention Deficit Hyperactivity Disorder
Exclusion criteria: Children with autism spectrum disorder - Children with epilepsy
Intervention groups
children with attention deficit hyperactivity disorder
Main outcome variables
The amount of theta to beta
This is a parameter extracted from the brain signal that is related to focus or attention.
The value of theta to beta is actually the ratio of the amplitude of theta frequency band to the amplitude of the beta frequency band.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200306046705N1
Registration date:2020-05-01, 1399/02/12
Registration timing:retrospective
Last update:2020-05-01, 1399/02/12
Update count:0
Registration date
2020-05-01, 1399/02/12
Registrant information
Name
Mina Masoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 8670 5503
Email address
massoudi.mina@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-22, 1398/02/02
Expected recruitment end date
2019-05-20, 1398/02/30
Actual recruitment start date
2019-04-06, 1398/01/17
Actual recruitment end date
2019-06-22, 1398/04/01
Trial completion date
2019-10-23, 1398/08/01
Scientific title
Evaluation of a Cognitive Game with Neurofeedback on Cognitive and Behavioral functions in Children with Attention Deficit Hyperactivity Disorder
Public title
Evaluation of a Game based on Neurofeedback in Children with Attention Deficit Hyperactivity Disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with Attention Deficit Hyperactivity Disorder
Exclusion criteria:
Children with autism spectrum disorder
Children with epilepsy
Age
From 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Actual sample size reached:
4
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Children are unaware that they are playing with dynamic difficulty or playing with static difficulty.
Placebo
Not used
Assignment
Single
Other design features
Dynamic difficulty Adjustment of the Game based on the Performance and Attention of the participant
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University
Street address
Unit 5-217, Noor residential, Yas 7 Alley, Kharazmi 2 Avenue, Ghadir Blvd, Sepahanshahr
City
Isfahan
Province
Isfehan
Postal code
8179935897
Approval date
2017-11-15, 1396/08/24
Ethics committee reference number
IR.UI.REC.1399.002
Health conditions studied
1
Description of health condition studied
Attention Deficit Hyperactivity Disorder
ICD-10 code
F98
ICD-10 code description
Other behavioral and emotional disorders with onset usually occurring in childhood and adolescence
Primary outcomes
1
Description
Attention score
Timepoint
Before the intervention and after the intervention
Method of measurement
Integrated Visual and Auditory continuous performance test (IVA-test)
Secondary outcomes
1
Description
Behavioral functions Score
Timepoint
Before the intervention and after the intervention
Method of measurement
SNAP-IV questionnaire
Intervention groups
1
Description
Intervention group 1:In this group, the difficulty of the game changes dynamically throughout the game.
Category
N/A
2
Description
Intervention group 2:In this group, the difficulty of the game during the game is static.
Category
N/A
3
Description
Control group: : They do not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Learning Disorders Center (Area Counseling Center 3)
Full name of responsible person
Maryam Motamedi
Street address
next to Salman Pool, Alam Mosque Alley, next to Salman Pool
City
Isfahan
Province
Isfehan
Postal code
102109140000
Phone
+98 31 3624 7787
Email
learningdisorder@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cognitive Sciences & Technologies Council
Full name of responsible person
Deputy of Research and Technology
Street address
No. 35, Alvand Ave, Arzhantin square, Tehran
City
Tehran
Province
Tehran
Postal code
88194954
Phone
+98 21 8819 4956
Email
info@cogc.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cognitive Sciences & 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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Esfahan
Full name of responsible person
Mina Masoudi
Position
Master’s Degree
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
University of Isfahan, Hezarjirib Ave, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
009837932128
Email
massoudi.mina@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Javad Rasti
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
University of Isfahan, Hezarjirib Ave, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2128
Email
rasti@eng.ui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Mina Masoudi
Position
Masters Degree
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
University of Isfahan, Hezarjirib Ave, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3651 0767
Email
massoudi.mina@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Shareable
When the data will become available and for how long
After printing
To whom data/document is available
researchers
Under which criteria data/document could be used
No conditions
From where data/document is obtainable
Mina Masoudi
Phone Number:00989130895420
What processes are involved for a request to access data/document