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Attention Deficit Hyperactivity DisorderNCT04467658

Neurophysiological Marker of ADHD in Children

An observational study of Attention Deficit Hyperactivity Disorder and Psychiatric Diagnosis, run by Daegu Catholic University Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 7 to 12 yearsHealthy volunteers can take part
What is being tested?
electroencephalography absolute delta power, electroencephalography relative delta power and electroencephalography absolute theta power
Type of treatment
Injection or infusion
How many people
140 participants
Where
1 siteSouth Korea
Study dates
8 Aug 2018to 28 Feb 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Daegu Catholic University Medical Center

    Daegu, Nam-gu, 42471

Other trials in South Korea

About this study

Official title: Neurophysiological Marker of Attention Deficit Hyperactivity Disorder in Children

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.

Read the detailed description

Participants between 7 and 12 years of age diagnosed with ADHD according to the DSM-5 criteria were included in the study. The ADHD diagnosis was based on a Korean version of the Diagnostic Interview Schedule for Children Version IV (DISC-IV), which is a structured interview tool, and these diagnoses were confirmed by multiple child and adolescent psychiatrists. If participants did not meet the ADHD diagnostic criteria of DSM-IV and DISC-IV, they were assigned to the Neurotypical (NT) group. Based on the results of the DISC-IV test, participants were assigned to the ADHD or Non-Other Specified (NOS) group. Patients who met the diagnostic criteria of ADHD in DSM-IV, but whose score did not exceed six, and had a score of more than three in the attention deficit or hyperactivity/impactivity scale of DISC-IV were included in the NOS group. 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. The EEG recordings were performed using a SynAmps2 direct-current (DC) amplifier and a 10-20 layout 64-channel Quick-Cap electrode-placement system (Neuroscan Inc., NC, USA). The EEG data were digitally recorded from 19 gold cup electrodes placed according to the international 10-20 system. The impedances were maintained below 5 kΩ, and the sampling rate was 1000 Hz. The investigators use the linked mastoid reference and two additional bipolar electrodes to measure horizontal and vertical eye movements. During the recording, each participant laid in a dimly lit, electrically shielded, sound-attenuated room. Resting EEG recordings were recorded after three minutes with the participants' eyes closed.

Being tested
electroencephalography absolute delta power, electroencephalography relative delta power, electroencephalography absolute theta power, electroencephalography relative theta power, electroencephalography absolute slow alpha power
Keywords
ADHD, QEEG, Neurotypical
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electroencephalography absolute delta powerDiagnostic test

    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

  • electroencephalography relative delta powerDiagnostic test

    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

  • electroencephalography absolute theta powerDiagnostic test

    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

  • electroencephalography relative theta powerDiagnostic test

    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

  • electroencephalography absolute slow alpha powerDiagnostic test

    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

  • electroencephalography relative slow alpha powerDiagnostic test

    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

  • electroencephalography absolute fast alpha powerDiagnostic test

    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

  • electroencephalography relative fast alpha powerDiagnostic test

    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

  • electroencephalography absolute beta powerDiagnostic test

    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

  • electroencephalography relative beta powerDiagnostic test

    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

  • Korean ADHD rating scaleDiagnostic test

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

  • Korean Version of Diagnostic Interview Schedule for Children Version IVDiagnostic test

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

Study groups in NCT04467658
Study groupRoleWhat they receive
ADHDNot described
Receives: Diagnostic Test: electroencephalography absolute delta power; Diagnostic Test: electroencephalography relative delta power; Diagnostic Test: electroencephalography absolute theta power; Diagnostic Test: electroencephalography relative theta power; Diagnostic Test: electroencephalography absolute slow alpha power; Diagnostic Test: electroencephalography relative slow alpha power; Diagnostic Test: electroencephalography absolute fast alpha power; Diagnostic Test: electroencephalography relative fast alpha power; Diagnostic Test: electroencephalography absolute beta power; Diagnostic Test: electroencephalography relative beta power; Diagnostic Test: Korean ADHD rating scale; Diagnostic Test: Korean Version of Diagnostic Interview Schedule for Children Version IV
NT NeuroTypicalNot described
Receives: Diagnostic Test: electroencephalography absolute delta power; Diagnostic Test: electroencephalography relative delta power; Diagnostic Test: electroencephalography absolute theta power; Diagnostic Test: electroencephalography relative theta power; Diagnostic Test: electroencephalography absolute slow alpha power; Diagnostic Test: electroencephalography relative slow alpha power; Diagnostic Test: electroencephalography absolute fast alpha power; Diagnostic Test: electroencephalography relative fast alpha power; Diagnostic Test: electroencephalography absolute beta power; Diagnostic Test: electroencephalography relative beta power; Diagnostic Test: Korean ADHD rating scale; Diagnostic Test: Korean Version of Diagnostic Interview Schedule for Children Version IV
ADHD NOSNot described
Receives: Diagnostic Test: electroencephalography absolute delta power; Diagnostic Test: electroencephalography relative delta power; Diagnostic Test: electroencephalography absolute theta power; Diagnostic Test: electroencephalography relative theta power; Diagnostic Test: electroencephalography absolute slow alpha power; Diagnostic Test: electroencephalography relative slow alpha power; Diagnostic Test: electroencephalography absolute fast alpha power; Diagnostic Test: electroencephalography relative fast alpha power; Diagnostic Test: electroencephalography absolute beta power; Diagnostic Test: electroencephalography relative beta power; Diagnostic Test: Korean ADHD rating scale; Diagnostic Test: Korean Version of Diagnostic Interview Schedule for Children Version IV

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2020
  2. Study start8 Aug 2018
  3. Primary completion28 Feb 2021
  4. Study completion28 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04467658
Sponsor's protocol ID
CR-18-096
Status last verified
Feb 2024
First submitted
1 Jul 2020
Last updated
20 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data will be shared on request for proper reason

Questions about this trial

What is this clinical trial studying?

An observational study of Attention Deficit Hyperactivity Disorder and Psychiatric Diagnosis, run by Daegu Catholic University Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

QEEG topographical plots of the results of the statistical comparisons to normative values (z-scores) using Neuroguide software (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.

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