Evaluation of neurofeedback effect on the executive functions of children with ADHD treated with methylphenidate
Design
Clinical trials with community-based control group, with parallel groups, simple triangular randomized triangles
Settings and conduct
The samples were randomly selected from Razi Hospital and personal offices and were studied using a blinded three-way method.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
The definitive diagnosis of ADHD according to DSM-IV-TR criteria
age 5- 14 Years old
consent to attend the study through the signing of informed consent
Exclusion Criteria:
Taking medications other than ADHD drugs-attention deficit
History of Head trauma
Concomitant major psychiatric disorders such as psychosis
History of Epilepsy
Serious medical illness
Receive simultaneously Medical treatments or psychological treatments
History of diagnosed mental retardation
Unwillingness of the patient or parents to continue to attend the plan
Incomplete parenting questionnaire
Students with obvious organic diseases
Intervention groups
Methylphenidate consumer group
Mentelenidity and neurofeedback consumer group
Main outcome variables
Change in score of Conners' Parent Questionnaire, Change in score of CPT-2, Change in score (Wave) of QEEG
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140825018927N6
Registration date:2018-07-22, 1397/04/31
Registration timing:retrospective
Last update:2018-07-22, 1397/04/31
Update count:0
Registration date
2018-07-22, 1397/04/31
Registrant information
Name
Seyed Gholamreza Noorazar
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3382 6512
Email address
noorazars@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2016-12-21, 1395/10/01
Actual recruitment end date
2017-07-06, 1396/04/15
Trial completion date
empty
Scientific title
Effect of Neuro feedback on Executive Functions of Children with ADHD Who Treated with Methylphenidate in razi Hospital of Tabriz
Public title
Effect of Neuro feedback on ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The ADHD according to DSM-IV-TR criteria
age 5- 14 Years old
consent to attend the study through the signing of informed consent
Exclusion criteria:
history of head trauma
the Co-morbidity of major psychiatric disorders such as psychosis
history of seizures
there is a serious medical condition
get medical treatment or psychological
Age
From 5 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
After selecting the patient, a simple randomization method was used to replace the methylphenidate group or methylphenidate with the neurofeedback.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The researcher and evaluator and analyst of the data were not aware of which group (methylphenidate or methylphenidate with neurofeedback) the sample was. Of course each sample has an special code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz-Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5183974511
Approval date
2016-02-18, 1394/11/29
Ethics committee reference number
IR.TBZMED.REC.1394.1070
Health conditions studied
1
Description of health condition studied
Attention deficit hyperactivity disorder (ADHD)
ICD-10 code
F90.0
ICD-10 code description
Attention-deficit hyperactivity disorder, predominantly inattentive type
Primary outcomes
1
Description
Hyperactivity, Inattention/ Cognition
Timepoint
Before the intervention, three months after the intervention.
Method of measurement
Connor's parents questionnaire, CPT2 Test, QEEG Test
Secondary outcomes
1
Description
Change in score of Conners' Parent Questionnaire
Timepoint
Before the intervention, three months after
Method of measurement
Conners' Parent Questionnaire
2
Description
Change in score of CPT-2
Timepoint
Before the intervention, three months after
Method of measurement
Continuous Performance Test (CPT-2)
3
Description
Change in score (Wave) of QEEG
Timepoint
Before the intervention, three months after
Method of measurement
Quantitative Electroencephalography (QEEG)
Intervention groups
1
Description
intervention group: Patients will receive 0.5 to 1 mg/kg/day methylphenidate tablet daily with Neuro feedback (third session in week) for 3 month.
Category
Treatment - Devices
2
Description
Intervention group2: Patients will receive 0.5 to 1 mg/kg/day methylphenidate tablet daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Psychiatry at the University of Medical Sciences
Full name of responsible person
seyed Golamreza Noorazar
Street address
Razi Hospital, elgoli road
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
noorazars@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Tabriz University of Medical Sciences, Golgasht Street, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
noorazars@tbzmed.ac.ir
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
Proportion provided by this source
100
Public or private sector
Private
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Noorazar
Position
Associate Professor / Professor of Child and Adolescent Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Razi Hospital-Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41309143117825
Fax
Email
Noorazars@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roghayeh Nasiri
Position
Resident of Psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Razi Hospital-Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41309144198409
Fax
Email
R.Nasiri60@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roghayeh Nasiri
Position
Resident of Psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Rasi Hospital-Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Fax
Email
R.Nasiri60@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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