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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: grupo de control
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Experimental: trail group
add 40Hz synchronized audiovisual stimulation.
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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ADHD-related behavioral scores at 3 and 6 months postoperatively
Periodo de tiempo: 1，3，6 month
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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.
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1，3，6 month
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Resting-state prefrontal gamma-band relative power spectral density (PSD, 35-45 Hz)
Periodo de tiempo: 1month
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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.
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1month
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Magnitude of early postoperative gamma-band suppression
Periodo de tiempo: 1month
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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.
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1month
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Hui Wang-2026.7
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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