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

NCT07719465 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-22

No results posted yet for this study

Summary

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.

Conditions

  • ADHD - Attention Deficit Disorder With Hyperactivity

Interventions

DEVICE

40-Hz non-invasive synchronized audiovisual stimulation

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.

Sponsors & Collaborators

  • General Hospital of Ningxia Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2027-08-01
Completion
2027-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07719465 on ClinicalTrials.gov