Clinical Study of Non-invasive 40-Hz Audiovisual Stimulation Guided by Gamma EEG Monitoring for Promoting Perioperative Brain Function Recovery in Children

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3-6
SponsorGeneral Hospital of Ningxia Medical University

About this trial

Exposure to general anesthesia during early brain development has emerged as an important risk factor for long-term attention-deficit/hyperactivity disorder (ADHD)-like behaviors and learning difficulties in school-aged children. However, objective biomarkers for perioperative neurofunctional assessment and effective non-invasive physical interventions remain lacking in clinical practice.

This study adopts a prospective randomized controlled trial (RCT) design to establish a clinical cohort of preschool children undergoing surgery under general anesthesia. Early postoperative intervention will be performed using 40-Hz non-invasive synchronized audiovisual stimulation. Portable electroencephalography (EEG) technology will be employed to quantify prefrontal gamma oscillatory activity by analyzing the relative gamma-band power spectrum and phase-locking index (PLI) during the perioperative period. The study aims to characterize the pathological suppression of gamma oscillations following general anesthesia and to evaluate the restorative effects of 40-Hz stimulation on gamma-band neural activity. Long-term postoperative follow-up, combined with the Conners Rating Scales and the Child Behavior Checklist (CBCL), will be conducted to systematically investigate the association between gamma oscillation restoration and improvements in long-term ADHD-like symptoms.

The successful completion of this project will establish an integrated pediatric postoperative neurorehabilitation strategy encompassing screening, intervention, and outcome evaluation, thereby providing a novel clinical approach with substantial translational potential and broad prospects for clinical implementation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged 3-6 years, irrespective of sex, representing the critical period of brain network development.

Disqualifiers

A preoperative diagnosis of autism spectrum disorder (ASD), epilepsy, intellectual developmental disorder, attention-deficit/hyperactivity disorder (ADHD), or any other neurological or psychiatric disorder.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 40-Hz non-invasive synchronized audiovisual stimulation

    Device

    Early postoperative intervention will be performed using 40-Hz non-invasive synchronized audiovisual stimulation. Portable electroencephalography (EEG) technology will be employed to quantify prefrontal gamma oscillatory activity by analyzing the relative gamma-band power spectrum and phase-locking index (PLI) during the perioperative period.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: control groupNo intervention 0 interventions
Group B: trail groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ADHD-related behavioral scores at 3 and 6 months postoperatively

Behavioral outcomes will be assessed using the Conners' Parent Rating Scale-Short Form (CPRS-S). Primary analyses will focus on the Hyperactivity-Impulsivity and Learning Problems (Inattention) subscales.

Time frame
1,3,6 month
2

Resting-state prefrontal gamma-band relative power spectral density (PSD, 35-45 Hz)

Resting-state EEG recordings will be obtained during postoperative follow-up to quantify the relative gamma-band power spectral density (35-45 Hz), serving as an objective indicator of cumulative recovery of cortical neural synchronization.

Time frame
1month

Secondary outcomes

1

Magnitude of early postoperative gamma-band suppression

The percentage reduction in prefrontal gamma-band EEG power during the immediate post-anesthesia recovery period relative to the preoperative baseline will be calculated to evaluate the sensitivity of gamma oscillations as an electrophysiological biomarker of anesthesia-induced brain dysfunction.

Time frame
1month

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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