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

Internet Addiction Clinical Trial

Official title:

The Effect of the Mobile EEG-Neurofeedback in Healthy Child and Adolescent Participants: a Randomized Sham-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06388655
• Other study ID #: MDCR-19-007
• Status: Completed
• Phase: N/A
• Start date: June 10, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2024
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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)

Related Conditions & MeSH terms

• Behavior, Addictive
• Internet Addiction

Intervention

Device:
• 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.
• sham 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.

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu	Nam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	through study completion, an average of 1 year
Secondary	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)	through study completion, an average of 1 year
Secondary	Comparisons of the means of children's K-WISC-IV(Korean Wechsler Intelligence Scale for Children-IV)	Participants' intelligence levels were assessed using measures	through study completion, an average of 1 year
Secondary	Comparisons of the means of children's Stroop	Participants' attention levels were assessed using measures	through study completion, an average of 1 year
Secondary	Comparisons of the means of children's ATA(Advanced Test of Attention)	Participants' attention levels were assessed using measures	through study completion, an average of 1 year
Secondary	Comparisons of the means of children's CCTT(Children's Color Trails Test)	Participants' attention levels were assessed using measures	through study completion, an average of 1 year