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

ConditionADHD - Attention Deficit Disorder With Hyperactivity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-18

SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: active stimulationActive comparator 1 intervention

Group B: sham stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame