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NCT Number: NCT07719465

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Classified as American Society of Anesthesiologists (ASA) Physical Status I or II.

Scheduled to undergo elective single-session surgery under general anesthesia (including inhalational anesthesia with agents such as sevoflurane) with an expected anesthesia duration of ≥1 hour, including procedures such as inguinal hernia repair, orchiopexy, and adenoidectomy.

Normal preoperative neurodevelopment as assessed by routine clinical evaluation, with parents or legal guardians able to understand the study protocol and willing to provide written informed consent.

Exclusion criteria

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

Severe visual impairment (e.g., cataract or amblyopia) or significant hearing impairment that would preclude the administration of synchronized audiovisual stimulation.

A personal or family history of photosensitive epilepsy, owing to safety considerations.

Occurrence of major anesthesia-related complications during surgery, including severe allergic reactions, malignant hyperthermia, prolonged severe hypoxemia, or other serious perioperative adverse events.

Treatment and study plan

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.

Primary outcomes

  1. ADHD-related behavioral scores at 3 and 6 months postoperatively

    Time frame: 1,3,6 month

    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.

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

    Time frame: 1month

    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.

Secondary outcomes

  1. Magnitude of early postoperative gamma-band suppression

    Time frame: 1month

    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.

Sponsors and collaborators

Lead sponsor

General Hospital of Ningxia Medical University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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