Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Continuous Performance Task
研究概览
简要总结
Inattentiveness and impulsivity in healthy adults and individuals with attention deficit hyperactivity disorder (ADHD) diminish these individuals' quality of life. Cortical hypometabolism has been hypothesized to contribute to inattentiveness in ADHD. Transcranial photobiomodulation (tPBM) is a safe and non-invasive modality for activation of the prefrontal cortex. tPBM in healthy adults has been shown to augment brain oxygenation, cognition, and mood. The cognition-enhancing effect of tPBM on sustained attention in adults with ADHD remains unstudied. The investigators will evaluate whether tPBM administration to adults with and without ADHD can improve their attention. Each participant will be screened for eighteen criteria based on the Diagnostic and Statistical Manual (DSM-IV, text revised), using the validated instrument Adult ADHD Self-Report Scale (ASRS-v1.1). Blinded participants will be randomized into (I) Active-tPBM or (II) Sham-tPBM groups. After undergoing an 8-minute administration of Sham or 1064 nm tPBM to the lateral and medial right prefrontal cortex, each participant will complete a 14-minute, computer-based Conner's continuous performance task-3 (CPT-3). The investigators will examine whether adults with and without ADHD who receive Active-tPBM improve in measures of inattention, impulsivity, sustained attention, or vigilance compared to the Sham-tPBM group. Cognitive assessments of attention like the CPT-3 may evaluate the efficacy of tPBM to increase cortical metabolism in healthy adults and individuals with conditions like ADHD. The investigators anticipate their investigation will be a starting point for more sophisticated studies that focus on the implications of tPBM on cognition.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
排除标准
- 未提供
研究组 & 干预措施
tPBM, non-ADHD
Participants with no medical diagnosis of ADHD will be exposed to the same conditions as sham participants, with the exception that the infrared light will be turned on (treated condition).
干预措施: Transcranial photobiomodulation (Device)
tPBM, ADHD
Participants with a medical diagnosis of ADHD will be exposed to the same conditions as sham participants, with the exception that the infrared light will be turned on (treated condition).
干预措施: Transcranial photobiomodulation (Device)
Sham-tPBM, non-ADHD
Participants with no medical diagnosis of ADHD will be exposed to the same conditions as treated participants, with the exception that the infrared light will be turned off (sham condition).
干预措施: Sham transcranial photobiomodulation (Device)
Sham-tPBM, ADHD
Participants with a medical diagnosis of ADHD will be exposed to the same conditions as treated participants, with the exception that the infrared light will be turned off (sham condition).
干预措施: Sham transcranial photobiomodulation (Device)
结局指标
主要结局
Continuous Performance Task
时间窗: Up to two months
Measure of inattention, impulsivity, sustained attention, vigilance
次要结局
- Functional near-infrared spectroscopy(Up to two months)
研究者
Francisco Gonzalez-Lima, PhD
Professor
University of Texas at Austin
