Attention Deficit Hyperactivity Disorder (ADHD)NCT07154732
Transcranial Photobiomodulation With Multiple Interventions in Children With Attention-Deficit/Hyperactivity Disorder
A study testing Transcranial photobiomodulation (active) in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Qilu Hospital of Shandong University.
Trial summary
To investigate the therapeutic efficacy of transcranial photobiomodulation (tPBM) with multiple interventions in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Transcranial photobiomodulation (active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 Jan 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To investigate the therapeutic efficacy of transcranial photobiomodulation (tPBM) with multiple interventions in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). The study evaluates intervention effects at Magnetic Resonance Imaging, electrophysiological, Visual Search Task, cognitive-behavioral, and clinical symptom levels, aiming to identify the optimal clinical treatment regimen for ADHD patients.
- Being tested
- Transcranial photobiomodulation (active), Transcranial photobiomodulation (sham)
- Keywords
- transcranial Light Stimulation (tLS), transcranial photobiomodulation (tPBM), Attention Deficit Hyperactivity Disorder (ADHD), Electroencephalography (EEG)
- 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.
Transcranial photobiomodulation (active)Device
During the active stimulation period, participants completed 11 sessions of active stimulation within 11 days in their own homes. The stimulation duration per session was 9-12 minutes, administered once daily.
Transcranial photobiomodulation (sham)Device
During the sham stimulation period, participants completed 11 sessions of sham stimulation in their own homes within 11 days, with the same stimulation frequency and duration as the active stimulation group. The intervention was delivered at the same target area and wavelength; the intensity was matched to that of the active stimulation during the first 30 seconds and the last 30 seconds of each session, while no intervention was applied in the intermediate period.
| Study group | Role | What they receive |
|---|---|---|
| Active tPBM session | Active comparator | During the active stimulation period, participants completed 11 sessions of active stimulation within 11 days in their own homes. The stimulation duration per session was 9-12 minutes, administered once daily. Receives: Device: Transcranial photobiomodulation (active) |
| Sham tPBM session | Sham comparator | During the sham stimulation period, participants completed 11 sessions of sham stimulation in their own homes within 11 days, with the same stimulation frequency and duration as the active stimulation group. The intervention was delivered at the same target area and wavelength; the intensity was matched to that of the active stimulation during the first 30 seconds and the last 30 seconds of each session, while no intervention was applied in the intermediate period. Receives: Device: Transcranial photobiomodulation (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swanson, Nolan, and Pelham Version IV(SNAP-IV)
The Swanson, Nolan, and Pelham Version IV (SNAP-IV) scale includes a total score and three subset scores, with higher scores indicating more severe ADHD symptoms.
Measured: From enrollment to one week after the end of the second group's intervention.
Sleep Disturbances Scale for Children(SDSC)
The Sleep Disturbances Scale for Children (SDSC) is a widely used standardized tool designed to assess sleep problems in children and adolescents (typically aged 6-18 years). It evaluates various dimensions of sleep disturbances, with subscales (subsets) that target specific types of sleep disorders. Higher scores indicate more prominent sleep problems.
Measured: From enrollment to one week after the end of the second group's intervention.
Behavioral Inhibition/Activation System Scales (BIS/BAS)
The Behavioral Inhibition/Activation System Scales (BIS/BAS) is a widely used self-report instrument designed to assess individual differences in two fundamental motivational systems proposed by Gray's reinforcement sensitivity theory: the Behavioral Inhibition System (BIS) and the Behavioral Activation System (BAS). High BIS scores: Indicate a heightened sensitivity to negative stimuli, punishment, or potential threats. BAS scores primarily reflect sensitivity to positive stimuli/rewards: Higher scores = greater motivation, impulsivity, or approach behavior; lower scores = reduced reward responsiveness or motivation. The BAS scale typically includes three subscales.
Measured: From enrollment to one week after the end of the second group's intervention.
Secondary outcomes (5)
EEG(Electroencephalogram)
Electroencephalogram (EEG) was recorded during participants' performance of a visual search task. The primary analyses focused on the latency and amplitude of the N2pc waveform, as well as the power spectra of bands such as alpha, during the task performance both before and after the intervention.
Measured: From enrollment to one week after the end of the second group's intervention.
Executive Function Task
Participants completed an executive function task following active and sham stimuli to compare the effects of transcranial light stimulation(tLS) on the improvement of executive function in children with ADHD.
Measured: From enrollment to one week after the end of the second group's intervention.
Visual Search Task
At the start of the task, participants were required to fixate on the central fixation point on the screen. Subsequently, a search matrix was presented briefly before disappearing. Participants needed to judge the location of the target, move the joystick, and press the confirmation button to terminate the trial.
Measured: From enrollment to one week after the end of the second group's intervention.
Photobiomodulation Subjective Assessment Scale
Measured: From enrollment to one week after the end of the second group's intervention.
Magnetic Resonance Imaging
Participants underwent magnetic resonance imaging scans before and after the interventions in both groups to clarify the intervention effects of the active and sham stimulus groups.
Measured: From enrollment to one week after the end of the second group's intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154732
- Sponsor's protocol ID
- QL000006
- Status last verified
- Aug 2025
- First submitted
- 20 Jul 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Photobiomodulation With Multiple Interventions in Children With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT07154732
- Acronym / sponsor ID
- QL000006
- Keywords
- transcranial Light Stimulation (tLS), transcranial photobiomodulation (tPBM), Attention Deficit Hyperactivity Disorder (ADHD), Electroencephalography (EEG)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 4 Sep 2025 (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.
To investigate the therapeutic efficacy of transcranial photobiomodulation (tPBM) with multiple interventions in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). The study evaluates intervention effects at Magnetic Resonance Imaging, electrophysiological, Visual Search Task, cognitive-behavioral, and clinical symptom levels, aiming to identify the optimal clinical treatment regimen for ADHD patients.
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 tPBM session | Active comparator | Device: Transcranial photobiomodulation (active)During the active stimulation period, participants completed 11 sessions of active stimulation within 11 days in their own homes. The stimulation duration per session was 9-12 minutes, administered once daily. |
| Sham tPBM session | Sham comparator | Device: Transcranial photobiomodulation (sham)During the sham stimulation period, participants completed 11 sessions of sham stimulation in their own homes within 11 days, with the same stimulation frequency and duration as the active stimulation group. The intervention was delivered at the same target area and wavelength; the intensity was matched to that of the active stimulation during the first 30 seconds and the last 30 seconds of each session, while no intervention was applied in the intermediate period. |
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 |
|---|---|---|
| Transcranial photobiomodulation (active)During the active stimulation period, participants completed 11 sessions of active stimulation within 11 days in their own homes. The stimulation duration per session was 9-12 minutes, administered once daily. | Device | Active tPBM session |
| Transcranial photobiomodulation (sham)During the sham stimulation period, participants completed 11 sessions of sham stimulation in their own homes within 11 days, with the same stimulation frequency and duration as the active stimulation group. The intervention was delivered at the same target area and wavelength; the intensity was matched to that of the active stimulation during the first 30 seconds and the last 30 seconds of each session, while no intervention was applied in the intermediate period. | Device | Sham tPBM session |
Primary outcome
Swanson, Nolan, and Pelham Version IV(SNAP-IV)
Time frame: From enrollment to one week after the end of the second group's intervention.
The Swanson, Nolan, and Pelham Version IV (SNAP-IV) scale includes a total score and three subset scores, with higher scores indicating more severe ADHD symptoms.
Sleep Disturbances Scale for Children(SDSC)
Time frame: From enrollment to one week after the end of the second group's intervention.
The Sleep Disturbances Scale for Children (SDSC) is a widely used standardized tool designed to assess sleep problems in children and adolescents (typically aged 6-18 years). It evaluates various dimensions of sleep disturbances, with subscales (subsets) that target specific types of sleep disorders. Higher scores indicate more prominent sleep problems.
Behavioral Inhibition/Activation System Scales (BIS/BAS)
Time frame: From enrollment to one week after the end of the second group's intervention.
The Behavioral Inhibition/Activation System Scales (BIS/BAS) is a widely used self-report instrument designed to assess individual differences in two fundamental motivational systems proposed by Gray's reinforcement sensitivity theory: the Behavioral Inhibition System (BIS) and the Behavioral Activation System (BAS). High BIS scores: Indicate a heightened sensitivity to negative stimuli, punishment, or potential threats. BAS scores primarily reflect sensitivity to positive stimuli/rewards: Higher scores = greater motivation, impulsivity, or approach behavior; lower scores = reduced reward responsiveness or motivation. The BAS scale typically includes three subscales.
5 secondary outcomes
EEG(Electroencephalogram)
Time frame: From enrollment to one week after the end of the second group's intervention.
Executive Function Task
Time frame: From enrollment to one week after the end of the second group's intervention.
Visual Search Task
Time frame: From enrollment to one week after the end of the second group's intervention.
Photobiomodulation Subjective Assessment Scale
Time frame: From enrollment to one week after the end of the second group's intervention.
Magnetic Resonance Imaging
Time frame: From enrollment to one week after the end of the second group's intervention.
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 6 Oct 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial photobiomodulation (active) in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Qilu Hospital of Shandong 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 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: opening soon, as of the sponsor's last update on 6 Oct 2025. 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. 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?
Swanson, Nolan, and Pelham Version IV(SNAP-IV) (time frame: From enrollment to one week after the end of the second group's intervention.). The study lists 3 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 6 Oct 2025.