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

NCT06388655 | Completed

• 1 other identifier: MDCR-19-007
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Internet Addiction

Keywords

mobile neurofeedback; neurotypical; internet addiction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Comparisons of the means of parents' self-scale variables : 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)

  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)

  through study completion, an average of 1 year

• Comparisons of the means of children's Stroop

  through study completion, an average of 1 year

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

  through study completion, an average of 1 year

Study Arms (2)

MNF active group

EXPERIMENTAL

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

sham control group

SHAM COMPARATOR

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

Interventions

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.

MNF active group

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.

sham control group

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Daegu Catholic University Medical Center: lead

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, Nam-gu, 42471, South Korea

Location

MeSH Terms

Conditions

Internet Addiction Disorder

Condition Hierarchy (Ancestors)

Technology Addiction; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 29, 2024
• Study Start: June 10, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)