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Not yet recruiting NCT07154732

Transcranial Photobiomodulation With Multiple Interventions in Children With Attention-Deficit/Hyperactivity Disorder

No phase Interventional Attention Deficit Hyperactivity Disorder (ADHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial photobiomodulation (active), Transcranial photobiomodulation (sham).
Who it may be relevant to
Registry conditions: Attention Deficit Hyperactivity Disorder (ADHD). Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Swanson, Nolan, and Pelham Version IV(SNAP-IV) [Time frame: From enrollment to one week after the end of the second group's intervention.]
  • Sleep Disturbances Scale for Children(SDSC) [Time frame: From enrollment to one week after the end of the second group's intervention.]
  • Behavioral Inhibition/Activation System Scales (BIS/BAS) [Time frame: From enrollment to one week after the end of the second group's intervention.]
Secondary outcome measures (5)
  • 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.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07154732 · QL000006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗