Transcranial photobiomodulation (light therapy) for children and teens with ADHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting
• Qilu Hospital of Shandong University
  Jinan, Shandong, China Not yet recruiting

Study contacts

• Study coordinator: Aihua Cao, Post-doctoral
• Email: xinercah@163.com
• Phone: 18560086317

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.