Transcranial Photobiomodulation With Multiple Interventions in Children With Attention-Deficit/Hyperactivity Disorder

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorQilu Hospital of Shandong University

About this trial

To investigate the therapeutic efficacy of transcranial photobiomodulation (tPBM) with multiple interventions in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). The study evaluates intervention effects at Magnetic Resonance Imaging, electrophysiological, Visual Search Task, cognitive-behavioral, and clinical symptom levels, aiming to identify the optimal clinical treatment regimen 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

  • Transcranial photobiomodulation (active)
  • Transcranial photobiomodulation (sham)

Treatment groups

54 Participants
are divided into 2 treatment groups

Locations

This trial has no locations