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Effectiveness of a Mobile Neurofeedback for ADHD Youth

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

mobile neurofeedback

Sham mobile neurofeedback

medication + mobile neurofeedback

medication + Sham mobile neurofeedback

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Childrens' HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

mobile neurofeedback

sham control

medication +mobile neurofeedback

medication + sham control

Arm Description

Outcomes

Primary Outcome Measures

Korean Attention Deficit Hyperactivity Disorder rating scale

Clinical Global Impression Scale-Severity

Children's Global Assessment Scale

Secondary Outcome Measures

brain MRI

EEG power in beta band

EEG power in theta band

Near Infra-Red Spectroscopy

Full Information

NCT ID

NCT04469335

First Posted

July 7, 2020

Last Updated

July 8, 2020

Sponsor

Seoul National University Childrens Hospital

Collaborators

Hanyang University, Wonkwang University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04469335

Brief Title

Effectiveness of a Mobile Neurofeedback for ADHD Youth

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 7, 2020 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Childrens Hospital

Collaborators

Hanyang University, Wonkwang University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mobile neurofeedback

Arm Type

Experimental

Arm Title

sham control

Arm Type

Sham Comparator

Arm Title

medication +mobile neurofeedback

Arm Type

Experimental

Arm Title

medication + sham control

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

mobile neurofeedback

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham mobile neurofeedback

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

medication + mobile neurofeedback

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

medication + Sham mobile neurofeedback

Intervention Description

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.

Primary Outcome Measure Information:

Title

Korean Attention Deficit Hyperactivity Disorder rating scale

Time Frame

baseline

Title

Korean Attention Deficit Hyperactivity Disorder rating scale

Time Frame

2nd week

Title

Korean Attention Deficit Hyperactivity Disorder rating scale

Time Frame

4th week

Title

Korean Attention Deficit Hyperactivity Disorder rating scale

Time Frame

8th week

Title

Korean Attention Deficit Hyperactivity Disorder rating scale

Time Frame

third month

Title

Korean Attention Deficit Hyperactivity Disorder rating scale

Time Frame

sixth month

Title

Korean Attention Deficit Hyperactivity Disorder rating scale

Time Frame

twelfth month

Title

Clinical Global Impression Scale-Severity

Time Frame

baseline

Title

Clinical Global Impression Scale-Severity

Time Frame

2nd week

Title

Clinical Global Impression Scale-Severity

Time Frame

4th week

Title

Clinical Global Impression Scale-Severity

Time Frame

8th week

Title

Clinical Global Impression Scale-Severity

Time Frame

third month

Title

Clinical Global Impression Scale-Severity

Time Frame

sixth month

Title

Clinical Global Impression Scale-Severity

Time Frame

twelfth month

Title

Children's Global Assessment Scale

Time Frame

baseline

Title

Children's Global Assessment Scale

Time Frame

2nd week

Title

Children's Global Assessment Scale

Time Frame

4th week

Title

Children's Global Assessment Scale

Time Frame

8th week

Title

Children's Global Assessment Scale

Time Frame

third month

Title

Children's Global Assessment Scale

Time Frame

sixth month

Title

Children's Global Assessment Scale

Time Frame

twelfth month

Secondary Outcome Measure Information:

Title

brain MRI

Time Frame

at the beginning, third month, sixth month, twelfth month

Title

EEG power in beta band

Time Frame

at the beginning, third month, sixth month, twelfth month

Title

EEG power in theta band

Time Frame

at the beginning, third month, sixth month, twelfth month

Title

Near Infra-Red Spectroscopy

Time Frame

at the beginning, third month, sixth month, twelfth month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Boong Nyun Kim, MD, PhD

Phone

+82-10-3637-1558

kbn1@snu.ac.kr

Facility Information:

Facility Name

Seoul National University Childrens' Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Boong Nyun Kim, MD, PhD

Phone

+82-10-3637-1558

kbn1@snu.ac.kr

First Name & Middle Initial & Last Name & Degree

Boong Nyun Kim, MD, PhD

First Name & Middle Initial & Last Name & Degree

Inhyhang Kim, MD, PhD

First Name & Middle Initial & Last Name & Degree

Chan-Mo Yang, MD

First Name & Middle Initial & Last Name & Degree

Hyung Seo Park, MD

First Name & Middle Initial & Last Name & Degree

Minsup Shin, PhD

First Name & Middle Initial & Last Name & Degree

Gahye Noh, MD

First Name & Middle Initial & Last Name & Degree

Narae Yoon, MD

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of a Mobile Neurofeedback for ADHD Youth

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