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.
1 other identifier
interventional
165
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2020
CompletedStudy Start
First participant enrolled
July 7, 2020
CompletedFirst Posted
Study publicly available on registry
July 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJuly 14, 2020
July 1, 2020
1.5 years
July 7, 2020
July 8, 2020
Conditions
Outcome Measures
Primary Outcomes (21)
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 Outcomes (4)
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
Study Arms (4)
mobile neurofeedback
EXPERIMENTALsham control
SHAM COMPARATORmedication +mobile neurofeedback
EXPERIMENTALmedication + sham control
SHAM COMPARATORInterventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Childrens Hospitallead
- Hanyang Universitycollaborator
- Wonkwang University Hospitalcollaborator
Study Sites (1)
Seoul National University Childrens' Hospital
Seoul, 110-744, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 7, 2020
First Posted
July 14, 2020
Study Start
July 7, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
July 14, 2020
Record last verified: 2020-07