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IRCT20190317043079N2 IRCT 2021-03-19 Babol University of Medical Sciences The Effect of Neurofeedback/Biofeedback on Brain’s Waves Amplitude and Attention Deficit in Children With ADHD ADHD: Attention Deficit and Hyperactivity Disorder The effectiveness of Neurofeedback and Heart Rate Variability Training on QEEG Baseline and Sustained Attention in Children with ADHD 2021-04-09 anticipated 80 Complete https://irct.ir/trial/55030 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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 description: Participants are unaware of the allocation of study groups. N/A Attention Deficit/Hyperactivity Disorder. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group: Methylphenidate, twice-a-day oral administration contains 5 mg which may be increased in 10 mg increments at weekly intervals. Intervention 4: Third Intervention group: Methylphenidate along with Neurofeedback Group. Intervention 5: Fourth Intervention group:Methylphenidate along with NeuroBiofeedback Group. No - There is not a plan to make this available Justification or reason for not sharing IPD is Since study participants are patients with ADHD, there is no plan to publish participant data except in the final design report
public Soheila Hosseinzadeh
Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9592 hoseinzadeh_soheila@yahoo.com Babol University of Medical Sciences scientific Farzan Kheirkhah
Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9592 drfarzankh@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 7 years 12 years Both The identification of ADHD in children with other psychiatric and neurological disorders; Mental retardation F90 Attention-deficit hyperactivity disorders Rehabilitation Rehabilitation Treatment - Drugs Rehabilitation Rehabilitation 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 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 Control group: Methylphenidate, twice-a-day oral administration contains 5 mg which may be increased in 10 mg increments at weekly intervals Third Intervention group: Methylphenidate along with Neurofeedback Group Fourth Intervention group:Methylphenidate along with NeuroBiofeedback Group Baseline Quantitative Electroencephalography. Timepoint: before and after the study and a 6-month follow-up examination. Method of measurement: Electroencephalography. Sustained Attention and Impulsivity. Timepoint: before and after the study and a 6-month follow-up examination. Method of measurement: Continuous performance testing. 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. Babol University of Medical Sciences Approved 2021-03-13 Ethics Committee of Babol University of Medical Sciences Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)