NCT04467658

Brief Summary

This study investigated quantitative electroencephalography (QEEG) subtypes as auxiliary tools to assess Attention Deficit Hyperactivity Disorder (ADHD). Patient assessed using the Korean version of the Diagnostic Interview Schedule for Children Version IV and were assigned to one of three groups: ADHD, ADHD-Not Otherwise specified (NOS), and Neurotypical (NT). The investigators measure absolute and relative EEG power in 19 channels and conducted an auditory continuous performance test. The investigators analyzed QEEG according to the frequency range: delta (1-4 Hz), theta (4-8 Hz), slow alpha (8-10 Hz), fast alpha (10-13.5 Hz), and beta (13.5-30 Hz). The subjects were then grouped by Ward's method of cluster analysis using the squared Euclidian distance to measure dissimilarities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2.6 years

First QC Date

July 1, 2020

Last Update Submit

February 16, 2024

Conditions

Keywords

ADHDQEEGNeurotypical

Outcome Measures

Primary Outcomes (1)

  • QEEG topographical plots of the results of the statistical comparisons to normative values (z-scores) using Neuroguide software

    The investigators measures QEEG on first outpatient clinic and conduct topography for mapping

    through study completion, an average of 1 year

Study Arms (3)

ADHD

Diagnostic Test: electroencephalography absolute delta powerDiagnostic Test: electroencephalography relative delta powerDiagnostic Test: electroencephalography absolute theta powerDiagnostic Test: electroencephalography relative theta powerDiagnostic Test: electroencephalography absolute slow alpha powerDiagnostic Test: electroencephalography relative slow alpha powerDiagnostic Test: electroencephalography absolute fast alpha powerDiagnostic Test: electroencephalography relative fast alpha powerDiagnostic Test: electroencephalography absolute beta powerDiagnostic Test: electroencephalography relative beta powerDiagnostic Test: Korean ADHD rating scaleDiagnostic Test: Korean Version of Diagnostic Interview Schedule for Children Version IV

NT NeuroTypical

Diagnostic Test: electroencephalography absolute delta powerDiagnostic Test: electroencephalography relative delta powerDiagnostic Test: electroencephalography absolute theta powerDiagnostic Test: electroencephalography relative theta powerDiagnostic Test: electroencephalography absolute slow alpha powerDiagnostic Test: electroencephalography relative slow alpha powerDiagnostic Test: electroencephalography absolute fast alpha powerDiagnostic Test: electroencephalography relative fast alpha powerDiagnostic Test: electroencephalography absolute beta powerDiagnostic Test: electroencephalography relative beta powerDiagnostic Test: Korean ADHD rating scaleDiagnostic Test: Korean Version of Diagnostic Interview Schedule for Children Version IV

ADHD NOS

Diagnostic Test: electroencephalography absolute delta powerDiagnostic Test: electroencephalography relative delta powerDiagnostic Test: electroencephalography absolute theta powerDiagnostic Test: electroencephalography relative theta powerDiagnostic Test: electroencephalography absolute slow alpha powerDiagnostic Test: electroencephalography relative slow alpha powerDiagnostic Test: electroencephalography absolute fast alpha powerDiagnostic Test: electroencephalography relative fast alpha powerDiagnostic Test: electroencephalography absolute beta powerDiagnostic Test: electroencephalography relative beta powerDiagnostic Test: Korean ADHD rating scaleDiagnostic Test: Korean Version of Diagnostic Interview Schedule for Children Version IV

Interventions

We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings

ADHDADHD NOSNT NeuroTypical

We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings

ADHDADHD NOSNT NeuroTypical

We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings

ADHDADHD NOSNT NeuroTypical

We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings

ADHDADHD NOSNT NeuroTypical

We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings

ADHDADHD NOSNT NeuroTypical

We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings

ADHDADHD NOSNT NeuroTypical

We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings

ADHDADHD NOSNT NeuroTypical

We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings

ADHDADHD NOSNT NeuroTypical

We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings

ADHDADHD NOSNT NeuroTypical

We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings

ADHDADHD NOSNT NeuroTypical

The KARS is a standardized screening tool for ADHD in Korean children and rating scale completed by the parents.

ADHDADHD NOSNT NeuroTypical

The DISC-IV is a structured diagnostic tool that was developed for use in epidemiological studies in children and adolescents

ADHDADHD NOSNT NeuroTypical

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients who suspected attention-deficit/hyperactivity disorder conducted QEEG and diagnosed with DISC-IV

You may qualify if:

  • Participants between 7 and 12 years of age diagnosed with ADHD according to the DSM-5 criteria were included in the study

You may not qualify if:

  • Children with a history of brain damage, neurological disorders, genetic disorders, substance dependence, epilepsy, or any other mental disorder were excluded from participation.
  • Children with an IQ of 70 or lower according to the Korean-Wechsler Intelligence Scale for Children (Fourth Edition) or who were receiving drug treatment were also excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, Nam-gu, 42471, South Korea

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityMental Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 13, 2020

Study Start

August 8, 2018

Primary Completion

February 28, 2021

Study Completion

February 28, 2021

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Data will be shared on request for proper reason

Locations