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.
This study is conducted as a randomized triple-blind trial to investigate the effects of photobiomodulation therapy on ADHD. Initially, standardized assessment tools (physician ratings and parent self-reports) are employed to evaluate baseline clinical symptoms in ADHD patients who meet the inclusion and exclusion criteria. The experiment utilizes a within-subject design (within-subject factors: active versus sham stimulation), with each participant randomly assigned to receive two interventions-one active and one sham stimulation-administered in a counterbalanced order, with at least a one-week interval between the two sessions. Immediately following the intervention, standardized assessment tools are used to evaluate multidimensional clinical symptoms, and data related to executive function, including cognitive behavioral data, electroencephalographic data, and eye-tracking data, are collected. The intervention is carried out by trained technicians in accordance with the randomization results, while maintaining blinding for both clinical evaluators and participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
During the active stimulation condition, participants will receive a single session of tPBM intervention, lasting 12 minutes.
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.
Qilu Hospital of Shandong University
Jinan, Shandong, China
NOT_YET_RECRUITINGQilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGEEG(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: 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.
Time frame: From enrollment to the end of treatment at 3 weeks"
Swanson, Nolan, and Pelham Version IV
Participants completed the Swanson, Nolan, and Pelham Version IV (SNAP-IV) scale following active and sham stimuli to compare the effects of transcranial light biofeedback on the improvement of attention and hyperactivity-impulsivity symptoms in children with ADHD.
Time frame: From enrollment to the end of treatment at 3 weeks"
Sleep Disturbances Scale for Children
Participants completed the Sleep Disturbances Scale for Children (SDSC) scale following active and sham stimuli to compare the effects of transcranial Photobiomodulation on the improvement of sleep symptoms in children with ADHD.
Time frame: From enrollment to the end of treatment at 3 weeks"
Behavior Rating Inventory of Executive Function
Participants completed the Behavior Rating Inventory of Executive Function (BRIEF) scale following active and sham stimuli to compare the effects of transcranial Photobiomodulation on the improvement of attention control, emotional regulation, and behavioral inhibition in children with ADHD.
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Time frame: From enrollment to the end of treatment at 3 weeks"