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

NCT ID: NCT06685601

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2027-05-31

Brief 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.

Detailed Description

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.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

active stimulation

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

Group Type: ACTIVE_COMPARATOR

tPBM（active）

Intervention Type: DEVICE

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

sham stimulation

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.

Group Type: SHAM_COMPARATOR

tPBM（sham）

Intervention Type: DEVICE

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.

Interventions

tPBM（active）

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

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age between 6 and 18 years;

2. Clinically diagnosed with ADHD by a psychiatrist;

3. 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);

4. M.I.N.I. KID interview shows only ADHD, with no other comorbidities;

5. Able to cooperate with transcranial photobiomodulation.

6. 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 Criteria

1. Diagnosis of other severe mental illnesses, such as schizophrenia or bipolar disorder;

2. 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.;

3. Presence of significant structural brain abnormalities on imaging studies;

4. Presence of severe neurological diseases with a clear family history or potential risk;

5. Presence of metal implants or a pacemaker, or holes or fractures in the skull;

6. 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;

7. Raven's Progressive Matrices IQ score < 85.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: collaborator

Peking Union Medical College

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status: NOT_YET_RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Aihua Cao, Post-doctoral

Role: CONTACT

xinercah@163.com

18560086317

Facility Contacts

Yongheng Zhao, PhD candidate

Role: primary

zyh95817@163.com

15098893217

Other Identifiers

QL000005

Identifier Type: -

Identifier Source: org_study_id