Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06388655
Enrollment
61
Registered
2024-04-29
Start date
2019-06-10
Completion date
2022-06-30
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Internet Addiction

Keywords

mobile neurofeedback, neurotypical, internet addiction

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.

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.

Interventions

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.

Sponsors

Daegu Catholic University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
8 Years to 15 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Comparisons of the means of children's self-scale variablesthrough study completion, an average of 1 yearParticipants' condition regarding internet addiction, among other factors, was assessed using children's self-scales such as the Korea Internet Addiction Scale (K-scale).

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026