Effectiveness of a Mobile Neurofeedback for ADHD Youth

Study Overview
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Brief Summary
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Objective: Verification of ADHD Treatment Effectiveness of Mobile Neurofeedback to Subjects of Child and Youth with ADHD. Method: Mobile Neurofeedback Program is implemented for 165 ADHD patients aged 8 to 15 to verify their effectiveness by conducting pre-post evaluation. Prior to the implementation of the intervention, we conduct a survey with demographic information, behavioral characteristics, clinical global impression, neuropsychological test, brain MRI, NIRS and EEG. The drug naive subjects are randomly assigned to the mobile Neurofeedback group or Sham control group. The subjects on medication are randomly assigned to the mobile Neurofeedback group or Sham control group, In addition to the medication being administered. The intervention are conducted three times a week, twice a day, and 10-20 minutes for 12 weeks, and the effectiveness is assessed four times in advance, third month, sixth month and twelfth months. However, the Sham control group were provided the same machines and programs as the Neurofeedback exercise, but feedback is generated randomly regardless of ectroencephalogram change of the subjects.

Official Title
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Comparative Clinical Trial With Double-blind Randomized Sham Control and Additive Treatment Toward Efficacy of Mobile Neurofeedback for ADHD Youth : An Exploratory Study.

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Device: mobile neurofeedback
* Device: Sham mobile neurofeedback
* Device: medication + mobile neurofeedback
* Device: medication + Sham mobile neurofeedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient between the ages of 8 and 15 Patients diagnosed with ADHD in accordance with DSM-5 diagnostic criteria and K-SADS-PL ③ IQ 80 or higher ④ Neurofeedback or Sham treatment group include patients who have not received methylphenidate/atomoxetine medication in the past or who have been treated with methylphenidate less than a year and not taken methylphenidate/atomoxetine within four weeks of starting point of this study. medication+Neurofeedback or medication+Sham treatment group include ADHD patients undergoing methylphenidate or atomoxetine medication over the past month without changes in capacity. And ADHD patients whose CGI-S scale is 4 or higher. Exclusion Criteria: Patients diagnosed with congenital genetic disease Patients with a clear history of acquired brain damage, such as cerebral palsy. ③ Patients with convulsions, other neurological disorders, or uncorrected sensory disorders Patients with a history of schizophrenia, other childhood psychosis ⑤ IQ below 80 ⑥ Patient with obsessive compulsive disorder, major depression or bipolar disorder

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mobile neurofeedback<br> | Device: mobile neurofeedback<br>* to maximize usability and effectiveness, we would like to conduct a study that regulates theta/beta ratio using mobile app-based Neurofeedback Training Equipment (OmniCNS). The actual Neurofeedback training allows you to download and use the omnifit brain_Game, an application with an audio guide. After the pre-assessment, the researcher will provide guidance to subjects and carers on how to use the application, and demonstrate how to use it in practice. For 2 weeks, 4 weeks and 6 weeks, phone calls are conducted to check whether they are used or not and for any inconvenience. After 12 weeks of Neurofeedback training, the device is returned and post-evaluated. The application is equipped with four types of games and is instructed to use the three-day-a-week application. For Neurofeedback attention and cognitive training, use a headset with left and right frontal lobe 2 channel-EEG sensors to perform the game through feedback to see if it is concentrating well.<br>|
| Sham Comparator: sham control<br> | Device: Sham mobile neurofeedback<br>* It uses the sham devices and programs as the Neurofeedback, but it is not usually possible to obtain the expected effects of the Neurofeedback by providing random feedback regardless of actual brain waves. In case of Sham control group, parental education is conducted the same for each clinical evaluation, and in case of Sham control group, actual Neurofeedback is applied if patients and parents want it after the end of the study.<br>|
| Experimental: medication +mobile neurofeedback<br> | Device: medication + mobile neurofeedback<br>* The mobile needback is applied to patients who are taking methylphenidate or atomoxetine, which is a standard ADHD treatment, but have not been remissioned with more than 4 points of CGI-S.<br>|
| Sham Comparator: medication + sham control<br> | Device: medication + Sham mobile neurofeedback<br>* The sham mobile needback is applied to patients who are taking methylphenidate or atomoxetine, which is a standard ADHD treatment, but have not been remissioned with more than 4 points of CGI-S.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Korean Attention Deficit Hyperactivity Disorder rating scale |  | baseline | 
| Korean Attention Deficit Hyperactivity Disorder rating scale |  | 2nd week | 
| Korean Attention Deficit Hyperactivity Disorder rating scale |  | 4th week | 
| Korean Attention Deficit Hyperactivity Disorder rating scale |  | 8th week | 
| Korean Attention Deficit Hyperactivity Disorder rating scale |  | third month | 
| Korean Attention Deficit Hyperactivity Disorder rating scale |  | sixth month | 
| Korean Attention Deficit Hyperactivity Disorder rating scale |  | twelfth month | 
| Clinical Global Impression Scale-Severity |  | baseline | 
| Clinical Global Impression Scale-Severity |  | 2nd week | 
| Clinical Global Impression Scale-Severity |  | 4th week | 
| Clinical Global Impression Scale-Severity |  | 8th week | 
| Clinical Global Impression Scale-Severity |  | third month | 
| Clinical Global Impression Scale-Severity |  | sixth month | 
| Clinical Global Impression Scale-Severity |  | twelfth month | 
| Children's Global Assessment Scale |  | baseline | 
| Children's Global Assessment Scale |  | 2nd week | 
| Children's Global Assessment Scale |  | 4th week | 
| Children's Global Assessment Scale |  | 8th week | 
| Children's Global Assessment Scale |  | third month | 
| Children's Global Assessment Scale |  | sixth month | 
| Children's Global Assessment Scale |  | twelfth month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain MRI |  | at the beginning, third month, sixth month, twelfth month | 
| EEG power in beta band |  | at the beginning, third month, sixth month, twelfth month | 
| EEG power in theta band |  | at the beginning, third month, sixth month, twelfth month | 
| Near Infra-Red Spectroscopy |  | at the beginning, third month, sixth month, twelfth month |