Clinical trial NCT06388655: The Effect of the Mobile EEG-Neurofeedback in Healthy Child and Adolescent
Official title: The Effect of the Mobile EEG-Neurofeedback in Healthy Child and Adolescent Participants: a Randomized Sham-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Internet Addiction
Keywords: mobile neurofeedback
neurotypical
internet addiction
Lead sponsor: Daegu Catholic University Medical Center
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 61
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Comparisons of the means of children's self-scale variables
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Comparisons of the means of parents' self-scale variables : Beck Depression Inventory-II (BDI-II)
timeFrame: through study completion, an average of 1 year
measure: Comparisons of the means of parents' self-scale variables : Beck Anxiety Inventory (BAI)
timeFrame: through study completion, an average of 1 year
measure: Comparisons of the means of children's K-WISC-IV(Korean Wechsler Intelligence Scale for Children-IV)
timeFrame: through study completion, an average of 1 year
measure: Comparisons of the means of children's Stroop
timeFrame: through study completion, an average of 1 year
measure: Comparisons of the means of children's ATA(Advanced Test of Attention)
timeFrame: through study completion, an average of 1 year
measure: Comparisons of the means of children's CCTT(Children's Color Trails Test)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
state: Nam-gu
Study officials:
References: