Comparison the therapeutic effect of neurofeedback and sham neurofeedback in the treatment of mathematics disorder in third-grade elementary school children
Objectives: Treatment of learning disorders has particular importance and Neurofeedback is rather new treatment. The aim of present study is to evaluate the efficiency of neurofeedback therapy in the treatment of mathematical disorder as a special learning disorder which described as the significant unreasonable delay in the ability of the calculating. Methods: In this study 28 children in the third grade of elementary school with mathematical disorder discovered by the psychiatric interview and Diagnostic and Statistical Manual of Mental Disorders guideline (DSM IV), along with educational records, have been evaluated. Participants including major eligibility criteria: None of the individuals have any Neurological and psychiatric disorders other than learning disorder. IQ scores are at least 70. Intervention: All children will be tested by mathematical disorder diagnosing and Wechsler Intelligence Scale. Then they are randomly divided into two equal groups in terms of age, gender, IQ score, mathematical disorder points and annual income. One group is received neurofeedback therapy and another group is received sham Neurofeedback. In the case of parents tendency, all children receive private education in mathematics. Each child will be received 20 of at least 30 minutes sessions neurofeedback therapy by treatment duration of 10-12 weeks. For placebo treatment, all the situations are exactly similar to the real neurofeedback treatment except the starting tone and its continuity which is random, without consideration of electroencephalogram (EEG) activity. Before the treatment, EEG will be taken from each child. Main outcome: After twenty therapy sessions, the mathematical disorder test and EEG are recorded for all the patients. Ratio of alpha to theta will be recorded before and after the each session. Furthermore all the patients will be followed three months and one year after completing the treatment by mathematical disorder test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306189175N6
Registration date:2013-09-13, 1392/06/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-13, 1392/06/22
Registrant information
Name
Lida Jarahi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 9262
Email address
jarahil@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mashhad University of Medical Sciences
Expected recruitment start date
2011-10-11, 1390/07/19
Expected recruitment end date
2013-10-11, 1392/07/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the therapeutic effect of neurofeedback and sham neurofeedback in the treatment of mathematics disorder in third-grade elementary school children
Public title
Evaluation of neurofeedback therapy in children with mathematics disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: without any neurological and psychiatric disorders, except learning disorder, IQ scores are at least 70, having the abnormal electroencephalogram (EEG) in alpha/theta, third elementary school grade
Exclusion criteria: any neurological and psychiatric disorders, having the normal electroencephalogram (EEG) in alpha/theta, age more than 10 and lower than 9
Age
From 9 years old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is done using a random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences
City
Mashhad
Postal code
Approval date
2011-03-01, 1389/12/10
Ethics committee reference number
511/3829
Health conditions studied
1
Description of health condition studied
Specific disorder of arithmetical skills
ICD-10 code
F81.2
ICD-10 code description
Involves a specific impairment in arithmetical skills that is not solely explicable on the basis of general mental retardation or of inadequate schooling. The deficit concerns mastery of basic computational skills of addition, subtraction, multiplication,
Primary outcomes
1
Description
Mathematic disorder
Timepoint
At the first and end of each 20 treatment sessions, 3 months and 1 year after completing the treatment
Method of measurement
Mathematic scale and Educational records
Secondary outcomes
empty
Intervention groups
1
Description
For intervention group: Mathematical education in 20 sessions will be done. Then Neurofeedback treatment according to the record program PROCOMP 2 in 20 sessions, at least 30 minutes during 10-12 weeks will be done
Category
Treatment - Devices
2
Description
For control group: Mathematical education in 20 sessions will be done. Then similar to the neurofeedback treatment according to the record program PROCOMP 2 in 20 sessions, at least 30 minutes during 10-12 weeks will be done. But start tone and its continuity is without consideration of electroencephalogram activity randomly
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychiatry and Behavioral Sciences Research Center
Full name of responsible person
Dr Peiman Hashemian
Street address
Ibn Sina Hospital, Hor Amerli Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Peiman Hashemian
Position
Child and Adolescent Psychiatrist
Other areas of specialty/work
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue,boo Ali square
City
Mashhad
Postal code
Phone
+98 51 1888 2926
Fax
Email
hashemianp@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Peiman Hashemian
Position
Child and Adolescent Psychiatrist
Other areas of specialty/work
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue,boo Ali square
City
Mashhad
Postal code
Phone
+98 51 1888 2926
Fax
Email
hashemianp@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Peiman Hashemian
Position
Child and Adolescent Psychiatrist
Other areas of specialty/work
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue,boo Ali square
City
Mashhad
Postal code
Phone
+98 51 1888 2926
Fax
Email
hashemianp@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)