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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to one week after the end of the second group's intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aihua Cao, Post-doctoral | Contact | 18560086317 | xinercah@163.com |
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| 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. |
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| 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. | From enrollment to one week after the end of the second group's intervention. |
| 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. | 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 | Participants underwent magnetic resonance imaging scans before and after the interventions in both groups to clarify the intervention effects of the active and sham stimulus groups. | From enrollment to one week after the end of the second group's intervention. |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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