RecruitingNot ApplicableNCT06685601

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

An Intervention Study on Transcranial Photobiomodulation for Children With Attention-Deficit/Hyperactivity Disorder


Sponsor

Qilu Hospital of Shandong University

Enrollment

60 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 6 YearsMax Age: 18 Years

Inclusion Criteria6

  • 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;
  • Able to cooperate with transcranial photobiomodulation.
  • 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 Criteria7

  • 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;
  • Presence of metal implants or a pacemaker, or holes or fractures in the skull;
  • 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;
  • Raven's Progressive Matrices IQ score < 85.

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Interventions

DEVICEtPBM(active)

During the active stimulation condition, participants will receive a single session of tPBM intervention, lasting 12 minutes.

DEVICEtPBM(sham)

During the sham stimulation condition, participants will receive the same intervention with identical target areas and wavelength, but only for the first and last 30 seconds of the session.


Locations(2)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

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NCT06685601


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