MedTrace Logo

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

NCT07154732 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-10-06

No results posted yet for this study

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)

Interventions

DEVICE

Transcranial photobiomodulation (active)

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 (sham)

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.

Sponsors & Collaborators

  • Qilu Hospital of Shandong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-12-31
Completion
2027-01-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07154732 on ClinicalTrials.gov