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

NCT ID: NCT06388655

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2022-06-30

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.

Conditions

Internet Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

MNF active group

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.

Group Type: EXPERIMENTAL

mobile neurofeedback

Intervention Type: DEVICE

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 control group

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.

Group Type: SHAM_COMPARATOR

sham mobile neurofeedback

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daegu Catholic University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Junwon Kim

Clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Daegu Catholic University Medical Center

Daegu, Nam-gu, South Korea

Countries

South Korea

Other Identifiers

MDCR-19-007

Identifier Type: -

Identifier Source: org_study_id