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

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

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.

Study Overview

• Status: Completed
• Conditions: Internet Addiction
• Intervention / Treatment: Device: mobile neurofeedback; Device: sham mobile neurofeedback

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Nam-gu
    • Daegu, Nam-gu, Korea, Republic of, 42471
      • Daegu Catholic University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MNF active group; In this study, neurofeedback headsets developed by OmniCNS were utilized, employing a dry EEG method to measure EEG signals at a rate of 250Hz. Signals were then transformed into the frequency domain through Fourier transform, allowing assessment of power across a wide range of frequencies. Feedback activities, like levitation or running, were based on attention levels determined by the Low beta + Middle beta / Theta Power ratio. Participants received training and engaged in neurofeedback games through the Omnifit Brain app using the provided headsets and personal smartphones for 12 weeks, three times a week for 10-20 minutes per session. Four game types based on the theta/beta ratio were offered, allowing participants to choose freely.	Device: mobile neurofeedback; 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 Comparator: sham control group; 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.	Device: sham mobile neurofeedback; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparisons of the means of children's self-scale variables	Participants' condition regarding internet addiction, among other factors, was assessed using children's self-scales such as the Korea Internet Addiction Scale (K-scale).	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparisons of the means of parents' self-scale variables : Beck Depression Inventory-II (BDI-II)	The evaluation of participants was conducted using parents' self-scales : Beck Depression Inventory-II (BDI-II)	through study completion, an average of 1 year
Comparisons of the means of parents' self-scale variables : Beck Anxiety Inventory (BAI)	The evaluation of participants was conducted using parents' self-scales : Beck Anxiety Inventory (BAI)	through study completion, an average of 1 year
Comparisons of the means of children's K-WISC-IV(Korean Wechsler Intelligence Scale for Children-IV)	Participants' intelligence levels were assessed using measures	through study completion, an average of 1 year
Comparisons of the means of children's Stroop	Participants' attention levels were assessed using measures	through study completion, an average of 1 year
Comparisons of the means of children's ATA(Advanced Test of Attention)	Participants' attention levels were assessed using measures	through study completion, an average of 1 year
Comparisons of the means of children's CCTT(Children's Color Trails Test)	Participants' attention levels were assessed using measures	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Daegu Catholic University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: internet addiction; mobile neurofeedback; neurotypical
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Technology Addiction; Behavior, Addictive; Internet Addiction Disorder
• Other Study ID Numbers: MDCR-19-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No