Comparison of the effectiveness two neurofeedback methods: theta wave suppress/beta wave increase and theta wave suppress/alpha increase in improvement of cognitive functions in children with attention deficit hyperactivity disorder
This study is planned to comparison of two neurofeedback protocol in improvement of children's cognitive functions.
Among the 7 to 10 years children referring to Brozorgmehr Clinic of Tabriz university of medical sciences who are diagnosed Attention deficit and hyperactive disorder.
These children should be candidate for neurofeedback training protocol, considering inclusion and exclusion criterias. This study is a clinical trial type, with intervene an independence variant.
The included patients randomly replace in two group; one is theta Suppress/the other is high alpha increase protocol.
Two groups have the parents' Conner's Score for Attention deficit and hyperactive disorder four times; before the intervention (neurofeedback training), in 8th week, after 20 and 40 sessions of neurofeedback training.
They will graded according to their canner's Score.
For the cognitive functions, we will do the CPS (Continuous performance Scare) test four times as above and the results will compare between two groups.
The results will interpret with descriptive Statistical parameters (abundance percentage, mean and standard deviance.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404122660N4
Registration date:2015-02-02, 1393/11/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-02, 1393/11/13
Registrant information
Name
Shahrokh Amiri Aziza Abad
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1380 4486
Email address
amirish@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences , Vice chancellory for Research
Expected recruitment start date
2014-04-05, 1393/01/16
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness two neurofeedback methods: theta wave suppress/beta wave increase and theta wave suppress/alpha increase in improvement of cognitive functions in children with attention deficit hyperactivity disorder
Public title
Comparison of the effectiveness two neurofeedback methods: theta wave suppress/beta wave increase and theta wave suppress/alpha increase in improvement of cognitive functions in children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Attention deficit and hyperactive disorder diagnosis based on DSM-IV;
2) Age between 7 to 10 years old and
3) no psycho pharmacological or psychotherapies in last 6 months
Exclusion criteria:
History of head trauma;
Psychiatric co morbidity except opposition defiant disorder;
History of epilepsy;
Important medical disease;
Mental Retardation;
Concurrent psycho pharmacological or psychotherapies
Age
From 7 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee, vice chancellory for research of Tabriz University of Medical Sciences,
Street address
Golgasht Ave., Attar Neishaboory Ave.
City
Tabriz
Postal code
Approval date
2014-02-17, 1392/11/28
Ethics committee reference number
10347/4/5
Health conditions studied
1
Description of health condition studied
Attention Deficit-Hyperactivity Disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention
Primary outcomes
1
Description
canner's form scores for parents
Timepoint
Before the intervention / end of 8th week / after 20th session / after 40th session
Method of measurement
parent canner's form
Secondary outcomes
1
Description
Children's Cognitive functions
Timepoint
Before the intervention,8th week after intervention, after the 20th and 40th sessions
Method of measurement
Continious prformance test
Intervention groups
1
Description
Control group: Tetha suppress / Betha increase Protocole of Neurofeedback
Category
Treatment - Other
2
Description
Intervention group: Tetha suppress / Alpha increase Protcole of Neurofeedback
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bozrgmehr Clinic,Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shahrokh Amiri
Street address
Counter side of central post office, South Artesh Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences, Vice chancellory for Research
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Golgasht Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences, Vice chancellory for Research
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
Associate professor
Full name of responsible person
Dr Shahrokh Amiri
Position
Tabriz University of Medical Sciences, Research center of clinical psychiatry
Other areas of specialty/work
Street address
El goli
City
Tabriz
Postal code
Phone
+98 41 1382 5612
Fax
Email
Tbzpsyres@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi Hospital, Tabriz University of Medical Sciences
Full name of responsible person
Dr Shahrokh Amiri
Position
Associate professor
Other areas of specialty/work
Street address
Razi Hospital, El goli
City
Tabriz
Postal code
Phone
+98 41 1382 5612
Fax
Email
Amirish@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Razi Hospital, Tabriz University of Medical Sciences
Full name of responsible person
Dr Shahrikh Amiri
Position
Associate professor
Other areas of specialty/work
Street address
El goli
City
Tabriz
Postal code
Phone
+98 41 1328 5612
Fax
Email
Amirish@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)