An interventional study of mobile neurofeedback and sham mobile neurofeedback in Internet Addiction, sponsored by Daegu Catholic University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 8 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by Daegu Catholic University Medical Center · Not applicable, Interventional, and Prevention
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.
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.
166 studies on the registry are indexed under Internet Addiction Disorder; 47 are open to participants now.
This study's enrollment of 61 is below the median of 88 across 96 interventional studies indexed under Internet Addiction Disorder.
Browse Internet Addiction Disorder studies →Daegu Catholic University Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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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)
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 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 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.
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.
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).
Time frame: through study completion, an average of 1 year
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)
Time frame: 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)
Time frame: 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
Time frame: through study completion, an average of 1 year
Comparisons of the means of children's Stroop
Participants' attention levels were assessed using measures
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 1 year
Plan to share: No
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Daegu Catholic University Medical Center