Effectiveness of a Mobile Neurofeedback for ADHD Youth

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

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.

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Device: mobile neurofeedback; Device: Sham mobile neurofeedback; Device: medication + mobile neurofeedback; Device: medication + Sham mobile neurofeedback

• Study Type: Interventional
• Enrollment (Anticipated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Boong Nyun Kim, MD, PhD; Phone Number: +82-10-3637-1558; Email: kbn1@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Childrens' Hospital
    • Contact: Boong Nyun Kim, MD, PhD; Phone Number: +82-10-3637-1558; Email: kbn1@snu.ac.kr
    • Principal Investigator: Boong Nyun Kim, MD, PhD
    • Sub-Investigator: Inhyhang Kim, MD, PhD
    • Sub-Investigator: Chan-Mo Yang, MD
    • Sub-Investigator: Hyung Seo Park, MD
    • Sub-Investigator: Minsup Shin, PhD
    • Sub-Investigator: Gahye Noh, MD
    • Sub-Investigator: Narae Yoon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: mobile neurofeedback	Device: mobile neurofeedback; 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.
SHAM_COMPARATOR: sham control	Device: Sham mobile neurofeedback; 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.
EXPERIMENTAL: medication +mobile neurofeedback	Device: medication + mobile neurofeedback; 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.
SHAM_COMPARATOR: medication + sham control	Device: medication + Sham mobile neurofeedback; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Seoul National University Childrens Hospital
• Collaborators: Hanyang University; Wonkwang University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 7, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (ACTUAL): July 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 8, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 1905-145-1035

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No