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Completed

NCT Number: NCT06388655

The Effect of the Mobile EEG-Neurofeedback in Healthy Child and Adolescent

The objective of this study was to ascertain the therapeutic impact of mobile neurofeedback (MNF) in neurotypical children when compared to sham MNF. Clinical assessments were conducted both before and after the MNF intervention, and the effectiveness of the intervention was to be validated through these evaluations.

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Key information

Conditions

Internet Addiction Behavior Behavior, Addictive Compulsive Behavior Impulsive Behavior Internet Addiction Disorder Technology Addiction

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daegu Catholic University Medical Center

Daegu, Nam-gu, 42471, South Korea

About this study

Neurotypical children aged 10-15 participated in the study. All subjects were assessed using the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version Korean Version (K-SADS-PL-K) and confirmed to have no psychiatric symptoms. The participants were randomly assigned to the MNF active (N=31) or sham control (N=30) groups. The MNF program was administered using a mobile app (equipped with a headset with a 2-channel EEG sensor) for 30 min/day, 3 days/week, for 3 months. All participants and their parents completed self-report scales and participants complete neurocognitive function assessments including the continuous performance test, Stroop, children's color trails test-1 and 2, and intelligence test at baseline and after the 3-month MNF program.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Child participants ranging from 8 to 15 years of age, who were recruited from the Department of Psychiatry at Daegu Catholic University Medical Center between 2019 and 2021

Exclusion criteria

History of congenital genetic diseases History of brain damage History of neurological disorders History of psychiatric conditions such as schizophrenia spectrum disorder, autism spectrum disorder, obsessive-compulsive disorder, major depressive disorder, or bipolar disorder Participants with an IQ below 70, as determined by the Korean-Wechsler Intelligence Scale for Children-Fourth Edition (K-WISC-IV)

Treatment and study plan

mobile neurofeedback

Device

The participants were randomly assigned to the MNF active (N=31) or sham control (N=30) groups. The MNF program was administered using a mobile app (equipped with a headset with a 2-channel EEG sensor) for 30 min/day, 3 days/week, for 3 months.

sham mobile neurofeedback

Device

The sham neurofeedback was implemented through presenting randomized game outcomes, independent of real measurements. The scoring distribution was meticulously adjusted to achieve a realistic spectrum of results, prioritizing median scores to uphold uniformity in user experience.

Primary outcomes

  1. Comparisons of the means of children's self-scale variables

    Time frame: through study completion, an average of 1 year

    Participants' condition regarding internet addiction, among other factors, was assessed using children's self-scales such as the Korea Internet Addiction Scale (K-scale).

Secondary outcomes

  1. Comparisons of the means of parents' self-scale variables : Beck Depression Inventory-II (BDI-II)

    Time frame: through study completion, an average of 1 year

    The evaluation of participants was conducted using parents' self-scales : Beck Depression Inventory-II (BDI-II)

  2. Comparisons of the means of parents' self-scale variables : Beck Anxiety Inventory (BAI)

    Time frame: through study completion, an average of 1 year

    The evaluation of participants was conducted using parents' self-scales : Beck Anxiety Inventory (BAI)

  3. Comparisons of the means of children's K-WISC-IV(Korean Wechsler Intelligence Scale for Children-IV)

    Time frame: through study completion, an average of 1 year

    Participants' intelligence levels were assessed using measures

  4. Comparisons of the means of children's Stroop

    Time frame: through study completion, an average of 1 year

    Participants' attention levels were assessed using measures

  5. Comparisons of the means of children's ATA(Advanced Test of Attention)

    Time frame: through study completion, an average of 1 year

    Participants' attention levels were assessed using measures

  6. Comparisons of the means of children's CCTT(Children's Color Trails Test)

    Time frame: through study completion, an average of 1 year

    Participants' attention levels were assessed using measures

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Official study title

The Effect of the Mobile EEG-Neurofeedback in Healthy Child and Adolescent Participants: a Randomized Sham-control Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2024
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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