Clinical Trial

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

Not Yet Recruiting Phase 1
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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.
Trial Details
NCT Number NCT07719465
Lead Sponsor General Hospital of Ningxia Medical University
Conditions ADHD - Attention Deficit Disorder With Hyperactivity
Enrollment 80 participants
Start Date 2026-09-15
Primary Completion 2027-08-01 (estimated)
Study Completion 2027-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-22