Transcranial Photobiomodulation With Multiple Interventions in Children With Attention-Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 主要终点
- Swanson, Nolan, and Pelham Version IV(SNAP-IV)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Able to cooperate with transcranial photobiomodulation.
- •The participant and their guardian fully understand the study procedures and content and agree to participate in the study, signing the informed consent form.
排除标准
- •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;
- •Presence of metal implants or a pacemaker, or holes or fractures in the skull;
- •Currently undergoing other ADHD treatments (e.g., methylphenidate or other pharmacological treatments, behavioral therapy, etc.) or has discontinued such treatments for less than 2 weeks;
- •Raven's Progressive Matrices IQ score < 85.
研究组 & 干预措施
Active tPBM session
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.
干预措施: Transcranial photobiomodulation (active) (Device)
Sham tPBM session
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.
干预措施: Transcranial photobiomodulation (sham) (Device)
结局指标
主要结局
Swanson, Nolan, and Pelham Version IV(SNAP-IV)
时间窗: From enrollment to one week after the end of the second group's intervention.
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.
Sleep Disturbances Scale for Children(SDSC)
时间窗: From enrollment to one week after the end of the second group's intervention.
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.
Behavioral Inhibition/Activation System Scales (BIS/BAS)
时间窗: From enrollment to one week after the end of the second group's intervention.
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.
次要结局
- EEG(Electroencephalogram)(From enrollment to one week after the end of the second group's intervention.)
- Executive Function Task(From enrollment to one week after the end of the second group's intervention.)
- Visual Search Task(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(From enrollment to one week after the end of the second group's intervention.)