An Intervention Study on Transcranial Photobiomodulation in Children With Attention Deficit Hyperactivity Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorQilu Hospital of Shandong University

About this trial

This study aims to intervene in children and adolescents with ADHD using transcranial photobiomodulation, comparing its effects on executive function at the levels of electroencephalography (EEG), eye tracking, and cognitive behavior. The goal is to identify the most effective clinical treatment strategy for ADHD patients.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • tPBM(active)
  • tPBM(sham)

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Qilu Hospital of Shandong University

Lead sponsor

Capital Medical University

Collaborator

Peking Union Medical College

Collaborator

Chinese Academy of Medical Sciences

Collaborator