ADHD - Attention Deficit Disorder With HyperactivityPhase 1NCT07719465
Clinical Study of Non-invasive 40-Hz Audiovisual Stimulation Guided by Gamma EEG Monitoring for Promoting Perioperative Brain Function Recovery in Children
A Phase 1 study testing 40-Hz non-invasive synchronized audiovisual stimulation in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by General Hospital of Ningxia Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD - Attention Deficit Disorder With Hyperactivity
- What is being tested?
- 40-Hz non-invasive synchronized audiovisual stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 1 Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Being tested
- 40-Hz non-invasive synchronized audiovisual stimulation
- Keywords
- ADHD,post-anesthesia,infant,
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40-Hz non-invasive synchronized audiovisual stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Not described |
| trail group | Experimental | add 40Hz synchronized audiovisual stimulation. Receives: Device: 40-Hz non-invasive synchronized audiovisual stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD-related behavioral scores at 3 and 6 months postoperatively
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.
Measured: 1，3，6 month
Resting-state prefrontal gamma-band relative power spectral density (PSD, 35-45 Hz)
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.
Measured: 1month
Secondary outcomes (1)
Magnitude of early postoperative gamma-band suppression
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.
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHD - Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719465
- Sponsor's protocol ID
- Hui Wang-2026.7
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Non-invasive 40-Hz Audiovisual Stimulation Guided by Gamma EEG Monitoring for Promoting Perioperative Brain Function Recovery in Children
- ClinicalTrials.gov ID
- NCT07719465
- Acronym / sponsor ID
- Hui Wang-2026.7
- Keywords
- ADHD,post-anesthesia,infant,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | – |
| trail group | Experimental | Device: 40-Hz non-invasive synchronized audiovisual stimulationadd 40Hz synchronized audiovisual stimulation. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40-Hz non-invasive synchronized audiovisual stimulationEarly 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. | Device | trail group |
Primary outcome
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.
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.
1 secondary outcome
Magnitude of early postoperative gamma-band suppression
Time frame: 1month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 40-Hz non-invasive synchronized audiovisual stimulation in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by General Hospital of Ningxia Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD-related behavioral scores at 3 and 6 months postoperatively (time frame: 1，3，6 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.