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临床试验/NCT05802680
NCT05802680招募中不适用

Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation

Francisco Gonzalez-Lima, PhD1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年2月9日最近更新:
适应症
干预措施

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

Experimental

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

Experimental

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

Sham Comparator

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

Sham Comparator

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

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Francisco Gonzalez-Lima, PhD

Professor

University of Texas at Austin

研究点 (1)

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