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

Официальное название

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

Обзор

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.

Подробное описание

This study is conducted as a randomized triple-blind trial to investigate the effects of photobiomodulation therapy on ADHD. Initially, standardized assessment tools (physician ratings and parent self-reports) are employed to evaluate baseline clinical symptoms in ADHD patients who meet the inclusion and exclusion criteria. The experiment utilizes a within-subject design (within-subject factors: active versus sham stimulation), with each participant randomly assigned to receive two interventions-one active and one sham stimulation-administered in a counterbalanced order, with at least a one-week interval between the two sessions. Immediately following the intervention, standardized assessment tools are used to evaluate multidimensional clinical symptoms, and data related to executive function, including cognitive behavioral data, electroencephalographic data, and eye-tracking data, are collected. The intervention is carried out by trained technicians in accordance with the randomization results, while maintaining blinding for both clinical evaluators and participants.

Вмешательства

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

Первичные конечные точки

• EEG(Electroencephalogram) [Срок оценки: From enrollment to the end of treatment at 3 weeks"]
• Executive Function Task [Срок оценки: From enrollment to the end of treatment at 3 weeks"]

Вторичные конечные точки (3)

• Swanson, Nolan, and Pelham Version IV [Срок оценки: From enrollment to the end of treatment at 3 weeks"]
• Sleep Disturbances Scale for Children [Срок оценки: From enrollment to the end of treatment at 3 weeks"]
• Behavior Rating Inventory of Executive Function [Срок оценки: From enrollment to the end of treatment at 3 weeks"]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Qilu Hospital of Shandong University — Цзинань
• Qilu Hospital of Shandong University — Цзинань

Идентификаторы

NCT: NCT06685601 · QL000005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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