Actively Recruiting
Study of Transcranial Photobiomodulation Treatment for Children and Adolescents With ADHD
Led by Qilu Hospital of Shandong University · Updated on 2025-07-22
60
Participants Needed
2
Research Sites
25 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying children and adolescents aged 6 to 18 years with Attention-DeficitHyperactivity Disorder ADHD to evaluate the effects of transcranial photobiomodulation tPBM on executive function. This randomized, triple-blind trial compares active and sham stimulation to identify the most effective clinical treatment strategy for ADHD by measuring brain activity, eye movements, and cognitive behavior. Participants receive two interventions in a random order one active tPBM session lasting 12 minutes and one sham session where the device is applied only briefly at the start and end for a total of 1 minute. There is at least a one-week break between sessions to compare effects within each participant. The treatment is administered by trained technicians while keeping participants and evaluators unaware of which session is active or sham. During the study, clinical symptoms are assessed using standardized rating tools completed by physicians and parents before and after each intervention. Researchers collect data on cognitive tasks, electroencephalography EEG, and eye tracking to evaluate executive function. The main outcomes are measured from enrollment through the 3-week treatment period. Safety and symptom changes are also monitored throughout the study duration.
CONDITIONS
Brief Title
An Intervention Study on Transcranial Photobiomodulation in Children With Attention Deficit Hyperactivity Disorder
Research Team
A
Aihua Cao, Post-doctoral
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