Transcranial Photobiomodulation for Adult ADHD
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 主要终点
- 4-weeks effect of t-PBM
研究概览
简要总结
This study aims to assess the behavioral as well cognitive changes in ADHD symptoms in terms of improvement of inhibitory control and attention in adults with ADHD
详细描述
This study is a randomized double blind trial. After selection and enrollment, participants will be screened at baseline with a complete diagnostic and clinical assessment, and randomized to receive active or placebo t-PBM.
At visit 1 patients will undergo a (pre-treatment) neuropsychological testing followed by the first t-PBM session. After the first t-PBM session, the patients will undergo another (post-treatment) neuropsychological testing. After visit 1, which includes the first treatment, patients will receive additional 4 weeks of t-PBM treatments. After the last treatment, patients will come to clinic for undergo a clinical and neuropsychological assessment (visit 2). After the visit 2, patients will receive other 4 weeks of t-PBM treatments. After the last t-PBM treatment session, patients will come to clinic to undergo the final clinical and neuropsychological assessment (visit 3).
At the visits 1, 2 and 3 patients will be asked if they believe they received active or sham treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects diagnosed with ADHD
排除标准
- •schizophrenia or other psychosis
- •current acute depressive episode
- •bipolar disorder with current manic or depressive episode
- •active substance use disorder
- •dementia.
结局指标
主要结局
4-weeks effect of t-PBM
时间窗: 1 month
To assess the effects of 4 weeks PBM treatment in terms of improvement of inhibitory control, as assessed through the Stop Signal Task
8-weeks effect of t-PBM
时间窗: 2 months
To assess the behavioral/cognitive and clinical changes of 8 weeks PBM treatment in terms of improvement of inhibitory control and normalization of intra-individual reaction time variability, as assessed through the Stop Signal Task, as well reduction of ADHD symptoms severity
次要结局
未报告次要终点