Protocol summary

Study aim
The effectiveness of Neurofeedback and Heart Rate Variability Training on QEEG Baseline and Sustained Attention in Children with ADHD
Design
Randomized Controlled Trial
Settings and conduct
For monitoring treatment progression and clinical outcome, before and after the study and a 6-month follow-up examination; the relations between baseline difference in quantitative electroencephalography, continuous performance testing and Connors rating scale of parents will be determined.
Participants/Inclusion and exclusion criteria
Children with Attention Deficit/Hyperactivity Disorder (ADHD), who are 7 to 12 years old, with definite diagnosis by a psychiatrist, based on DSM-V diagnostic criteria, semi-structured interview and developmental history; referred to the Psychiatric Clinic of Yahya Nejad Hospital and Private Center for Psychiatric Disorders. These criteria are based on such factors as co-occurrence of ADHD with other psychiatric and neurological disorders, mental retardation, as well as parents informed consent who agreed to allow their children to participate
Intervention groups
Eighty children with ADHD randomly divide into five experimental groups, namely a Neurofeedback (NFB) Group, two distinct theta/beta ratio and theta/sensorimotor rhythm training NFB protocols for a cumulative total of 30 minutes (15 minutes each) or more over a 45 minutes' period in 30 sessions/12 weeks, and Neurofeedback/ Biofeedback (BFB) Group, heart rate variability and respiratory BFB Group in which participants encouraged to breathe slowly and diaphragmally for 3-5 minutes, adapting inhalation and exhalation to heart rate fluctuations, and the other Methylphenidate, twice-a-day oral administration contains 5 mg which may be increased in 10 mg increments at weekly intervals, and Methylphenidate along with Neurofeedback and NeuroBiofeedback Groups.
Main outcome variables
Baseline QEEG; Attention, Impulsivity

General information

Reason for update
Acronym
ADHD: Attention Deficit and Hyperactivity Disorder
IRCT registration information
IRCT registration number: IRCT20190317043079N2
Registration date: 2021-03-19, 1399/12/29
Registration timing: prospective

Last update: 2021-03-19, 1399/12/29
Update count: 0
Registration date
2021-03-19, 1399/12/29
Registrant information
Name
farzan kheirkhah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1951
Email address
f.kheirkhah@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-09, 1400/01/20
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Neurofeedback and Heart Rate Variability Training on QEEG Baseline and Sustained Attention in Children with ADHD
Public title
The Effect of Neurofeedback/Biofeedback on Brain’s Waves Amplitude and Attention Deficit in Children With ADHD
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children 7-12 years with definite diagnosis of Attention Deficit/Hyperactivity Disorder by a psychiatrist, based on DSM-V diagnostic criteria, semi-structured interview and developmental history; referred to the Psychiatric Clinic of Yahya Nejad Hospital and Private Center for Psychiatric Disorders
Exclusion criteria:
The identification of ADHD in children with other psychiatric and neurological disorders; Mental retardation
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are randomly divided into 5 groups by block method. The size of the blocks is 10 and 8 blocks of 10 will be produced using a table of random numbers. Due to the fact that sampling is done in two centers, two samples of 80 lists will be produced, participants are assigned to two groups of 40 people.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2021-03-13, 1399/12/23
Ethics committee reference number
IR.MUBABOL.REC.1399.503

Health conditions studied

1

Description of health condition studied
Attention Deficit/Hyperactivity Disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders

Primary outcomes

1

Description
Baseline Quantitative Electroencephalography
Timepoint
before and after the study and a 6-month follow-up examination
Method of measurement
Electroencephalography

2

Description
Sustained Attention and Impulsivity
Timepoint
before and after the study and a 6-month follow-up examination
Method of measurement
Continuous performance testing

3

Description
Attention deficit and Impulsivity
Timepoint
before and after the study and a 6-month follow-up examination
Method of measurement
Connors rating scale of parents

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention group: Neurofeedback (NFB) Group, two distinct theta/beta ratio and theta/sensorimotor rhythm training NFB protocols 15 minutes each over a 45 minutes' period in 30 sessions/12 weeks
Category
Rehabilitation

2

Description
Second Intervention group: Neurofeedback and Heart Rate Variability Training and respiratory Biofeedback Group in which participants encouraged to breathe slowly and diaphragmally for 3-5 minutes, adapting inhalation and exhalation to heart rate fluctuations
Category
Rehabilitation

3

Description
Control group: Methylphenidate, twice-a-day oral administration contains 5 mg which may be increased in 10 mg increments at weekly intervals
Category
Treatment - Drugs

4

Description
Third Intervention group: Methylphenidate along with Neurofeedback Group
Category
Rehabilitation

5

Description
Fourth Intervention group:Methylphenidate along with NeuroBiofeedback Group
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Yahyanezhad Hospital
Full name of responsible person
Arman Masoudi
Street address
Modares St., Shahid Mostafa Khomeini St.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3222 3594
Email
yahyanejad@mubabol.ac.ir

2

Recruitment center
Name of recruitment center
Private Center for Psychiatric Disorders
Full name of responsible person
Farzan Kheirkhah
Street address
Sargard Ghasemi St., Pasargad Medical Center
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3225 7668
Email
drfarzankh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4718747415
Phone
+98 11 3219 0624
Email
alibijani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
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
Babol University of Medical Sciences
Full name of responsible person
Soheila Hosseinzadeh
Position
Assistant Professor of Neuroscience
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
hoseinzadeh_soheila@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Farzan Kheirkhah
Position
Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
drfarzankh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Soheila Hosseinzadeh
Position
Assistant Professor of Neuroscience
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
hoseinzadeh_soheila@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Since study participants are patients with ADHD, there is no plan to publish participant data except in the final design report
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
There is no plan to publish participant data
When the data will become available and for how long
After the publication of the final report of the project
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
If you need more information about the research, it will be available by sending an email to the main researchers.
From where data/document is obtainable
By sendind an E-mail to drfarzankh@yahoo.com, and hoseinzadeh_soheila@yahoo.com
What processes are involved for a request to access data/document
Within a maximum of one month after sending the email to the main researchers
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