Actively Recruiting
An Intervention Study on Transcranial Photobiomodulation for Children With Attention-Deficit/Hyperactivity Disorder
Led by Qilu Hospital of Shandong University · Updated on 2025-07-22
60
Participants Needed
2
Research Sites
25 weeks
Total Duration
On this page
Sponsors
Q
Qilu Hospital of Shandong University
Lead Sponsor
C
Capital Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying children and adolescents aged 6 to 18 years with Attention-Deficit/Hyperactivity 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 6 and 18 years
- Clinically diagnosed with ADHD by a psychiatrist
- Meets DSM-5 criteria for ADHD as confirmed by a child psychiatrist
- M.I.N.I. KID interview shows only ADHD with no other comorbidities
- Able to cooperate with transcranial photobiomodulation
- Participant and guardian understand the study and sign informed consent
You will not qualify if you...
- Diagnosis of other severe mental illnesses, such as schizophrenia or bipolar disorder
- Severe physical diseases or conditions including intracranial lesions, thyroid disorders, epilepsy, congenital heart disease, severe hematologic disorders, systemic lupus erythematosus, auditory or visual impairments
- Significant structural brain abnormalities on imaging
- Severe neurological diseases with family history or potential risk
- Presence of metal implants, pacemaker, or skull fractures
- Currently undergoing other ADHD treatments or discontinued such treatments less than 2 weeks ago
- Raven's Progressive Matrices IQ score below 85
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 weeks
Participants receive two sessions of transcranial photobiomodulation (tPBM) intervention in a randomized crossover design, including one active stimulation session lasting 12 minutes and one sham stimulation session. There is at least a one-week interval between the two sessions. Clinical symptoms and cognitive functions are assessed immediately after each intervention.
2 visits (in-person), with at least 1 week between sessions
Trial Site Locations
Total: 2 locations
1
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
2
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
Research Team
A
Aihua Cao, Post-doctoral
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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