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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorQilu Hospital of Shandong University

About this trial

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.

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

  • 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.

  • 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.

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Active tPBM sessionActive comparator 1 intervention
Group B: Sham tPBM sessionSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to one week after the end of the second group's intervention.
2

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.

Time frame
From enrollment to one week after the end of the second group's intervention.
3

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.

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

Secondary outcomes

1

EEG(Electroencephalogram)

Electroencephalogram (EEG) was recorded during participants' performance of a visual search task. The primary analyses focused on the latency and amplitude of the N2pc waveform, as well as the power spectra of bands such as alpha, during the task performance both before and after the intervention.

Time frame
From enrollment to one week after the end of the second group's intervention.
2

Executive Function Task

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

Time frame
From enrollment to one week after the end of the second group's intervention.
3

Visual Search Task

At the start of the task, participants were required to fixate on the central fixation point on the screen. Subsequently, a search matrix was presented briefly before disappearing. Participants needed to judge the location of the target, move the joystick, and press the confirmation button to terminate the trial.

Time frame
From enrollment to one week after the end of the second group's intervention.
4

Photobiomodulation Subjective Assessment Scale

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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