An Intervention Study on Transcranial Photobiomodulation for Children With Attention-Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- EEG(Electroencephalogram)
研究概览
简要总结
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.
详细描述
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.
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 stimulation
During the active stimulation condition, participants will receive a single session of tPBM intervention, lasting 12 minutes.
干预措施: tPBM（active） (Device)
sham stimulation
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.
干预措施: tPBM（sham） (Device)
结局指标
主要结局
EEG(Electroencephalogram)
时间窗: From enrollment to the end of treatment at 3 weeks"
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.
Executive Function Task
时间窗: From enrollment to the end of treatment at 3 weeks"
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.
次要结局
- Swanson, Nolan, and Pelham Version IV(From enrollment to the end of treatment at 3 weeks")
- Sleep Disturbances Scale for Children(From enrollment to the end of treatment at 3 weeks")
- Behavior Rating Inventory of Executive Function(From enrollment to the end of treatment at 3 weeks")