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

NCT06685601 | Recruiting

• 1 other identifier: QL000005
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

Keywords

tPBM; ADHD

Outcome Measures

Primary Outcomes (2)

• EEG(Electroencephalogram)

  The Electroencephalogram was recorded while participants performed a continuous attention task. The Negative 2-Posterior Contralateral(N2pc) waveform was analyzed, and a comparison of the N2pc waveforms following true and false stimuli was made to assess the improvement of attention in participants induced by transcranial light biofeedback.

  From enrollment to the end of treatment at 3 weeks"

• Executive Function Task

  Participants completed an executive function task following active and sham stimuli to compare the effects of transcranial Photobiomodulation on the improvement of executive function in children with ADHD.

  From enrollment to the end of treatment at 3 weeks"

Secondary Outcomes (3)

• Swanson, Nolan, and Pelham Version IV

  From enrollment to the end of treatment at 3 weeks"

• Sleep Disturbances Scale for Children

  From enrollment to the end of treatment at 3 weeks"

• Behavior Rating Inventory of Executive Function

  From enrollment to the end of treatment at 3 weeks"

Study Arms (2)

active stimulation

ACTIVE COMPARATOR

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

Device: tPBM（active）

sham stimulation

SHAM COMPARATOR

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.

Device: tPBM（sham）

Interventions

tPBM（active） DEVICE

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

active stimulation

tPBM（sham） 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.

sham stimulation

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Capital Medical University: collaborator
• Peking Union Medical College: collaborator
• Chinese Academy of Medical Sciences: collaborator

Study Sites (2)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Aihua Cao, Post-doctoral

CONTACT

18560086317; xinercah@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 12, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

CN (2)