Not Yet RecruitingPhase 1

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

80 participantsStarted 2026-09-15

Plain-language 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.

Who can participate

Age range

3 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is still in Phase 1 and hasn't started recruiting yet — what does that mean for how much is already known about whether 40-Hz light and sound stimulation is safe and effective for children with ADHD going through surgery?
2The study measures ADHD behavioral scores at 3 and 6 months after an operation — does my child have a surgery planned or coming up, and would that timing actually fit with what this trial requires?
3The trial uses EEG monitoring to track gamma brainwave activity in the prefrontal area — can you explain what that process looks like for a child, and is it something my child would be able to tolerate?
4Since this trial is focused on brain recovery around a surgical procedure, are there standard post-operative care approaches already available that we should consider first before looking at an experimental intervention like this?
5Because this is a Phase 1 study, the main goal is likely to establish safety rather than prove the treatment works — how would you weigh that against other ADHD management options we could pursue right now?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ADHD-related behavioral scores at 3 and 6 months postoperatively

Timeframe: 1，3，6 month

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

Timeframe: 1month

Trial details

NCT IDNCT07719465

SponsorGeneral Hospital of Ningxia Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-01

View on ClinicalTrials.gov More ADHD - Attention Deficit Disorder With Hyperactivity trials