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

NCT07154732 | Not Yet Recruiting

• 1 other identifier: QL000006
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

transcranial Light Stimulation (tLS); transcranial photobiomodulation (tPBM); Attention Deficit Hyperactivity Disorder (ADHD); Electroencephalography (EEG)

Outcome Measures

Primary Outcomes (3)

• Swanson, Nolan, and Pelham Version IV(SNAP-IV)

  The Swanson, Nolan, and Pelham Version IV (SNAP-IV) scale includes a total score and three subset scores, with higher scores indicating more severe ADHD symptoms.

  From enrollment to one week after the end of the second group's intervention.

• Sleep Disturbances Scale for Children(SDSC)

  The Sleep Disturbances Scale for Children (SDSC) is a widely used standardized tool designed to assess sleep problems in children and adolescents (typically aged 6-18 years). It evaluates various dimensions of sleep disturbances, with subscales (subsets) that target specific types of sleep disorders. Higher scores indicate more prominent sleep problems.

  From enrollment to one week after the end of the second group's intervention.

• Behavioral Inhibition/Activation System Scales (BIS/BAS)

  The Behavioral Inhibition/Activation System Scales (BIS/BAS) is a widely used self-report instrument designed to assess individual differences in two fundamental motivational systems proposed by Gray's reinforcement sensitivity theory: the Behavioral Inhibition System (BIS) and the Behavioral Activation System (BAS). High BIS scores: Indicate a heightened sensitivity to negative stimuli, punishment, or potential threats. BAS scores primarily reflect sensitivity to positive stimuli/rewards: Higher scores = greater motivation, impulsivity, or approach behavior; lower scores = reduced reward responsiveness or motivation. The BAS scale typically includes three subscales.

  From enrollment to one week after the end of the second group's intervention.

Secondary Outcomes (5)

• EEG(Electroencephalogram)

  From enrollment to one week after the end of the second group's intervention.

• Executive Function Task

  From enrollment to one week after the end of the second group's intervention.

• Visual Search Task

  From enrollment to one week after the end of the second group's intervention.

• Photobiomodulation Subjective Assessment Scale

  From enrollment to one week after the end of the second group's intervention.

• Magnetic Resonance Imaging

  From enrollment to one week after the end of the second group's intervention.

Study Arms (2)

Active tPBM session

ACTIVE COMPARATOR

During the active stimulation period, participants completed 11 sessions of active stimulation within 11 days in their own homes. The stimulation duration per session was 9-12 minutes, administered once daily.

Device: Transcranial photobiomodulation (active)

Sham tPBM session

SHAM COMPARATOR

During the sham stimulation period, participants completed 11 sessions of sham stimulation in their own homes within 11 days, with the same stimulation frequency and duration as the active stimulation group. The intervention was delivered at the same target area and wavelength; the intensity was matched to that of the active stimulation during the first 30 seconds and the last 30 seconds of each session, while no intervention was applied in the intermediate period.

Device: Transcranial photobiomodulation (sham)

Interventions

Transcranial photobiomodulation (active) DEVICE

During the active stimulation period, participants completed 11 sessions of active stimulation within 11 days in their own homes. The stimulation duration per session was 9-12 minutes, administered once daily.

Active tPBM session

Transcranial photobiomodulation (sham) DEVICE

During the sham stimulation period, participants completed 11 sessions of sham stimulation in their own homes within 11 days, with the same stimulation frequency and duration as the active stimulation group. The intervention was delivered at the same target area and wavelength; the intensity was matched to that of the active stimulation during the first 30 seconds and the last 30 seconds of each session, while no intervention was applied in the intermediate period.

Sham tPBM session

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

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: July 20, 2025
• First Posted: September 4, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-08