Transcranial photobiomodulation (light therapy) for children and teens with ADHD
An Intervention Study on Transcranial Photobiomodulation for Children With Attention-Deficit/Hyperactivity Disorder
This will test whether a noninvasive head-light treatment called transcranial photobiomodulation can improve attention and executive skills in children and adolescents with ADHD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 2 sites (Jinan, Shandong and 1 other locations) |
| Trial ID | NCT06685601 on ClinicalTrials.gov |
What this trial studies
This is a randomized, triple-blind, within-subject trial in which each participant receives one active and one sham transcranial photobiomodulation (tPBM) session in counterbalanced order with at least one week between sessions. Standardized clinical ratings and parent reports are collected at baseline and immediately after each session, while objective measures of executive function are gathered using cognitive tests, EEG, and eye tracking. Trained technicians deliver the interventions according to randomization while both participants and clinical evaluators remain blinded. The goal is to compare active versus sham stimulation effects to identify the most effective acute stimulation strategy for pediatric ADHD.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6–18 with a primary DSM-5 diagnosis of ADHD, no other psychiatric comorbidities, and the ability to cooperate with the procedure and attend in-person visits with parental consent.
Not a fit: Children with other psychiatric disorders, serious medical or neurologic conditions (for example epilepsy), sensory impairments, or those unable to cooperate with the procedures are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, tPBM could offer a noninvasive, drug-free option to improve attention and executive function in children with ADHD.
How similar studies have performed: Small pilot studies and early work with tPBM have reported some cognitive and neurophysiologic changes, but robust randomized controlled evidence in pediatric ADHD remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 6 and 18 years; 2. Clinically diagnosed with ADHD by a psychiatrist; 3. 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); 4. M.I.N.I. KID interview shows only ADHD, with no other comorbidities; 5. Able to cooperate with transcranial photobiomodulation. 6. 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: 1. Diagnosis of other severe mental illnesses, such as schizophrenia or bipolar disorder; 2. 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.; 3. Presence of significant structural brain abnormalities on imaging studies; 4. Presence of severe neurological diseases with a clear family history or potential risk; 5. Presence of metal implants or a pacemaker, or holes or fractures in the skull; 6. 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; 7. Raven's Progressive Matrices IQ score \< 85.
Where this trial is running
Jinan, Shandong and 1 other locations
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Not_yet_recruiting)
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Aihua Cao, Post-doctoral
- Email: xinercah@163.com
- Phone: 18560086317
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.