ADHD - Attention Deficit Disorder With HyperactivityNCT06685601
An Intervention Study on Transcranial Photobiomodulation in Children With Attention Deficit Hyperactivity Disorder
A study testing tPBM（active） in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by Qilu Hospital of Shandong University at 2 sites in China.
Trial summary
This study aims to intervene in children and adolescents with ADHD using transcranial photobiomodulation, comparing its effects on executive function at the levels of electroencephalography (EEG), eye tracking, and cognitive behavior. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- ADHD - Attention Deficit Disorder With Hyperactivity
- What is being tested?
- tPBM（active）
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 16 Dec 2024to May 2027
- Phase
- Interventional
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 6 and 18 years;
- Clinically diagnosed with ADHD by a psychiatrist;
- Confirmed by the researcher (child psychiatrist) to meet the diagnostic criteria for Attention-Deficit/Hyperactivity Disorder as outlined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- M.I.N.I. KID interview shows only ADHD, with no other comorbidities;
- Able to cooperate with transcranial photobiomodulation.
- The participant and their guardian fully understand the study procedures and content and agree to participate in the study, signing the informed consent form.
Who cannot join
- Diagnosis of other severe mental illnesses, such as schizophrenia or bipolar disorder;
- Presence of severe physical diseases or conditions, such as significant intracranial lesions, thyroid disorders, epilepsy, congenital heart disease, severe hematologic disorders, systemic lupus erythematosus, auditory or visual impairments, etc.;
- Presence of significant structural brain abnormalities on imaging studies;
- Presence of severe neurological diseases with a clear family history or potential risk;
- Presence of metal implants or a pacemaker, or holes or fractures in the skull;
- Currently undergoing other ADHD treatments (e.g., methylphenidate or other pharmacological treatments, behavioral therapy, etc.) or has discontinued such treatments for less than 2 weeks;
- Raven's Progressive Matrices IQ score < 85.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yongheng Zhao, PhD candidate, 15098893217, zyh95817@163.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
About this study
Official title: An Intervention Study on Transcranial Photobiomodulation for Children With Attention-Deficit/Hyperactivity Disorder
This study aims to intervene in children and adolescents with ADHD using transcranial photobiomodulation, comparing its effects on executive function at the levels of electroencephalography (EEG), eye tracking, and cognitive behavior. The goal is to identify the most effective clinical treatment strategy for ADHD patients.
Read the detailed description
This study is conducted as a randomized triple-blind trial to investigate the effects of photobiomodulation therapy on ADHD. Initially, standardized assessment tools (physician ratings and parent self-reports) are employed to evaluate baseline clinical symptoms in ADHD patients who meet the inclusion and exclusion criteria. The experiment utilizes a within-subject design (within-subject factors: active versus sham stimulation), with each participant randomly assigned to receive two interventions-one active and one sham stimulation-administered in a counterbalanced order, with at least a one-week interval between the two sessions. Immediately following the intervention, standardized assessment tools are used to evaluate multidimensional clinical symptoms, and data related to executive function, including cognitive behavioral data, electroencephalographic data, and eye-tracking data, are collected. The intervention is carried out by trained technicians in accordance with the randomization results, while maintaining blinding for both clinical evaluators and participants.
- Being tested
- tPBM（active）, tPBM（sham）
- Keywords
- tPBM, ADHD
- 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.
tPBM（active）Device
During the active stimulation condition, participants will receive a single session of tPBM intervention, lasting 12 minutes.
tPBM（sham）Device
During the sham stimulation condition, participants will receive the same intervention with identical target areas and wavelength, but only for the first and last 30 seconds of the session.
| Study group | Role | What they receive |
|---|---|---|
| active stimulation | Active comparator | During the active stimulation condition, participants will receive a single session of tPBM intervention, lasting 12 minutes. Receives: Device: tPBM（active） |
| sham stimulation | Sham comparator | During the sham stimulation condition, participants will receive the same intervention with identical target areas and wavelength, but only for the first and last 30 seconds of the session. Receives: Device: tPBM（sham） |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG(Electroencephalogram)
The Electroencephalogram was recorded while participants performed a continuous attention task. The Negative 2-Posterior Contralateral(N2pc) waveform was analyzed, and a comparison of the N2pc waveforms following true and false stimuli was made to assess the improvement of attention in participants induced by transcranial light biofeedback.
Measured: From enrollment to the end of treatment at 3 weeks"
Executive Function Task
Participants completed an executive function task following active and sham stimuli to compare the effects of transcranial Photobiomodulation on the improvement of executive function in children with ADHD.
Measured: From enrollment to the end of treatment at 3 weeks"
Secondary outcomes (3)
Swanson, Nolan, and Pelham Version IV
Participants completed the Swanson, Nolan, and Pelham Version IV (SNAP-IV) scale following active and sham stimuli to compare the effects of transcranial light biofeedback on the improvement of attention and hyperactivity-impulsivity symptoms in children with ADHD.
Measured: From enrollment to the end of treatment at 3 weeks"
Sleep Disturbances Scale for Children
Participants completed the Sleep Disturbances Scale for Children (SDSC) scale following active and sham stimuli to compare the effects of transcranial Photobiomodulation on the improvement of sleep symptoms in children with ADHD.
Measured: From enrollment to the end of treatment at 3 weeks"
Behavior Rating Inventory of Executive Function
Participants completed the Behavior Rating Inventory of Executive Function (BRIEF) scale following active and sham stimuli to compare the effects of transcranial Photobiomodulation on the improvement of attention control, emotional regulation, and behavioral inhibition in children with ADHD.
Measured: From enrollment to the end of treatment at 3 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start16 Dec 2024
- Primary completionNov 2026 (estimated)
- Study completionMay 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.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Medical University, Peking Union Medical College, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685601
- Sponsor's protocol ID
- QL000005
- Status last verified
- Jul 2025
- First submitted
- 5 Nov 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention Study on Transcranial Photobiomodulation for Children With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT06685601
- Acronym / sponsor ID
- QL000005
- Keywords
- tPBM, ADHD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Capital Medical University, Peking Union Medical College, Chinese Academy of Medical Sciences
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 Nov 2024 (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.
This study aims to intervene in children and adolescents with ADHD using transcranial photobiomodulation, comparing its effects on executive function at the levels of electroencephalography (EEG), eye tracking, and cognitive behavior. The goal is to identify the most effective clinical treatment strategy for ADHD patients.
Detailed description
This study is conducted as a randomized triple-blind trial to investigate the effects of photobiomodulation therapy on ADHD. Initially, standardized assessment tools (physician ratings and parent self-reports) are employed to evaluate baseline clinical symptoms in ADHD patients who meet the inclusion and exclusion criteria. The experiment utilizes a within-subject design (within-subject factors: active versus sham stimulation), with each participant randomly assigned to receive two interventions-one active and one sham stimulation-administered in a counterbalanced order, with at least a one-week interval between the two sessions. Immediately following the intervention, standardized assessment tools are used to evaluate multidimensional clinical symptoms, and data related to executive function, including cognitive behavioral data, electroencephalographic data, and eye-tracking data, are collected. The intervention is carried out by trained technicians in accordance with the randomization results, while maintaining blinding for both clinical evaluators and participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active stimulation | Active comparator | Device: tPBM（active）During the active stimulation condition, participants will receive a single session of tPBM intervention, lasting 12 minutes. |
| sham stimulation | Sham comparator | Device: tPBM（sham）During the sham stimulation condition, participants will receive the same intervention with identical target areas and wavelength, but only for the first and last 30 seconds of the session. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age between 6 and 18 years;
- Clinically diagnosed with ADHD by a psychiatrist;
- Confirmed by the researcher (child psychiatrist) to meet the diagnostic criteria for Attention-Deficit/Hyperactivity Disorder as outlined in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- M.I.N.I. KID interview shows only ADHD, with no other comorbidities;
- Able to cooperate with transcranial photobiomodulation.
Key exclusion criteria (7 listed)
- Diagnosis of other severe mental illnesses, such as schizophrenia or bipolar disorder;
- Presence of severe physical diseases or conditions, such as significant intracranial lesions, thyroid disorders, epilepsy, congenital heart disease, severe hematologic disorders, systemic lupus erythematosus, auditory or visual impairments, etc.;
- Presence of significant structural brain abnormalities on imaging studies;
- Presence of severe neurological diseases with a clear family history or potential risk;
- Presence of metal implants or a pacemaker, or holes or fractures in the skull;
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 |
|---|---|---|
| tPBM（active）During the active stimulation condition, participants will receive a single session of tPBM intervention, lasting 12 minutes. | Device | active stimulation |
| tPBM（sham）During the sham stimulation condition, participants will receive the same intervention with identical target areas and wavelength, but only for the first and last 30 seconds of the session. | Device | sham stimulation |
Primary outcome
EEG(Electroencephalogram)
Time frame: From enrollment to the end of treatment at 3 weeks"
The Electroencephalogram was recorded while participants performed a continuous attention task. The Negative 2-Posterior Contralateral(N2pc) waveform was analyzed, and a comparison of the N2pc waveforms following true and false stimuli was made to assess the improvement of attention in participants induced by transcranial light biofeedback.
Executive Function Task
Time frame: From enrollment to the end of treatment at 3 weeks"
Participants completed an executive function task following active and sham stimuli to compare the effects of transcranial Photobiomodulation on the improvement of executive function in children with ADHD.
3 secondary outcomes
Swanson, Nolan, and Pelham Version IV
Time frame: From enrollment to the end of treatment at 3 weeks"
Sleep Disturbances Scale for Children
Time frame: From enrollment to the end of treatment at 3 weeks"
Behavior Rating Inventory of Executive Function
Time frame: From enrollment to the end of treatment at 3 weeks"
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 2025.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tPBM（active） in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by Qilu Hospital of Shandong University at 2 sites in China.
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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Aihua Cao, Post-doctoral (18560086317, xinercah@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG(Electroencephalogram) (time frame: From enrollment to the end of treatment at 3 weeks"). 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 2025.