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

Daegu Catholic University Medical Center

Status: Completed

Conditions: Internet Addiction

Treatments: Device: mobile neurofeedback; Device: sham mobile neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT06388655

MDCR-19-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 8 to 15 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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61 participants in 2 patient groups

MNF active group

Experimental group

Description:

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.

Treatment:

Device: mobile neurofeedback

sham control group

Sham Comparator group

Description:

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.

Treatment:

Device: sham mobile neurofeedback