Effects of Transcranial Photobiomodulation on Cognition and Brain Metabolism in Adults With ADHD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Performance on the Continuous Performance Task
研究概览
简要总结
The investigators have previously shown that non-invasive methods of brain stimulation such as the administration of transcranial infrared light to the prefrontal cortex (PFC) can result in improvements to cognition and emotion as well as brain oxygenation. This method is called transcranial photobiomodulation (tPBM).
The investigators hypothesize that tPBM can improve cognition and brain oxygenation in adults with attention deficit hyperactivity disorder (ADHD). The investigators will investigate the effects of repeated tPBM sessions on cognitive functioning in adults with ADHD. Specifically, the investigators hypothesize that participants that receive tPBM will show improvements in response control, sustained attention, and working memory, as well as improvements in prefrontal hemodynamics and a reduction in ADHD symptoms.
详细描述
This will be a double-blind, sham-controlled study to evaluate the neurobehavioral and PFC neurometabolic effects of repeated tPBM sessions in adults with ADHD. Adults with a history of medically-diagnosed ADHD will be recruited. Participants will be randomized to two arms: (1) active tPBM or (2) sham tPBM. All participants will complete three in-person sessions and one remote follow-up visit conducted online. Participant will receive three weekly sessions of tPBM targeting the PFC using a 1064 nm laser. Cognitive performance will be assessed using the continuous performance task and 2-back task at baseline and after the final tPBM session. The investigators predict that participants receiving active tPBM will show improvements in sustained attention, impulse control, and working memory. Functional near-infrared spectroscopy recordings, collected at baseline and post-treatment, will be used to evaluate changes in PFC hemodynamic response and network interactions (functional connectivity). The investigators predict that active tPBM will enhance the PFC hemodynamic response and strengthen network interactions across prefrontal subregions. Lastly, ADHD symptomatology will be assessed using the Adult ADHD Self-Report Scale at baseline, post-treatment, and at a four-week follow-up after tPBM. The investigators predict that participants receiving active tPBM will report progressive reductions in ADHD symptoms across time points.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English-speaking
- •Adults of any sex
- •Age range: 18-44 years
- •Any ethnic/racial background
- •Medical history of ADHD
- •Participants may either be on a stable ADHD medication regimen (with no changes within two weeks prior to the study) or not taking medication.
排除标准
- •Currently pregnancy
- •Any sham or active photobiomodulation treatment within the past five weeks.
研究组 & 干预措施
Sham transcranial photobiomodulation
Participants in this arm will undergo this same procedure as the active group, but with no 1064-nm light emitted by the device.
干预措施: Sham transcranial photobiomodulation (Device)
Active transcranial photobiomodulation
Participants in this arm will receive active transcranial photobiomodulation to the forehead, targeting prefrontal cortex.
干预措施: Active transcranial photobiomodulation (Device)
结局指标
主要结局
Performance on the Continuous Performance Task
时间窗: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).
The Continuous Performance Task is a widely-used cognitive measure to evaluate sustained attention, vigilance, and response control. Participants respond to letters presented on a computer screen and inhibit their responses to the letter X. There is no score on a scale. An increase in Correct Rejections on CPT = better inhibition = better outcome of treatment.
Prefrontal oxygenation (functional near-infrared spectroscopy)
时间窗: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3).
Participants will wear a head-mounted functional near-infrared spectroscopy device that records changes in the concentrations of oxygenated hemoglobin potentially resulting from the treatment.
Scores on the Adult ADHD Self-Report Scale (ASRS) questionnaire
时间窗: 1. Pre-Treatment: Baseline (Visit 1). 2. Post-treatment: Two weeks later (Visit 3). 3. Follow-up: Four weeks later (Online).
The ASRS is an 18-question self-assessment tool created by the World Health Organization (WHO) which evaluates symptom severity of ADHD. Minimum score=18; maximum score=90; high score = more ADHD symptoms; lower score after treatment = better outcome.
次要结局
未报告次要终点
研究者
Francisco Gonzalez-Lima, PhD
Professor
University of Texas at Austin