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临床试验/NCT06203938
NCT06203938招募中不适用

Social and Behavioral Associations With Prefrontal Photobiomodulation in Autism Spectrum

Francisco Gonzalez-Lima, PhD1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2025年1月13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
280
试验地点
1
主要终点
Autism spectrum questionnaires

研究概览

简要总结

The investigators have previously shown that the administration of low-level infrared light is a safe and non-invasive procedure which improves cognition and emotion, as well as enhances brain metabolic activity. Based on previous studies, the investigators hypothesize that this methodology, called low-level light therapy or photobiomodulation, could be used to improve behavioral symptoms in individuals with autism spectrum disorder (ASD).

详细描述

The Gonzalez-Lima Laboratory at the University of Texas at Austin will be recruiting participants for a study investigating whether transcranial infrared light stimulation, or TILS, is beneficial for people diagnosed with autism spectrum disorder (ASD).

The molecular target of TILS is cytochrome c oxidase, a mitochondrial enzyme which is crucial for oxygen utilization. People with ASD show impaired mitochondrial function (Siddiqui, Elwell, and Johnson, 2016), as well as alterations in the prefrontal cortex (Amaral, Schumann, and Nordahl, 2008), which plays a key neurological role in mediating attention, impulse control, and social cognition functions.

The lab has previously shown that TILS, delivered to the prefrontal cortex, can be used to improve cognitive functions such as attention (Barrett and Gonzalez-Lima, 2013), executive function (Blanco, Maddox, and Gonzalez-Lima, 2017), and emotional regulation (Zaizar, Papini, Gonzalez-Lima, and Telch, 2021). This cognitive enhancement from TILS is accompanied by an increase in oxygenation of the prefrontal cortex (Holmes, Barrett, Saucedo, O'Connor, Liu, and Gonzalez-Lima, 2019). Recently, the beneficial effects of TILS on ASD symptoms have been safely explored in adults (Ceranoglu et al., 2022) and children/adolescents (Pallanti et al., 2022).

The goal of the study is to recruit children, adolescents, and adults, either ASD or non-ASD, for a study of the effects of repeated administration of TILS on autistic behavior. Participants will be asked to give informed consent, complete a series of questionnaires and cognitive tests, and wear a headband to non-invasively monitor brain activity using near-infrared spectroscopy. TILS is administered non-invasively with a headband device that uses light-emitting diodes (LEDs), which are cleared as safe for use in humans by the Food and Drug Administration (FDA), but the device has not been approved by the FDA for the specific investigational use in this research. The study will train participants (or caregivers) on how to use the LED device, then send the participants home to use the LED device. The investigators will contact participants once a week to check progress. At the end of the study, participants return for the same assessments, at which time the participants will return the LED device.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 4-60 years

排除标准

  • •Current pregnancy

研究组 & 干预措施

Sham

Sham Comparator

The sham control group undergoes the same procedure as the treatment group, but without the LEDs turned on.

干预措施: Sham (Device)

TILS-treated

Experimental

Transcranial infrared light stimulation (TILS) will be administered via light-emitting diodes (LEDs), which are a safe and non-invasive form of transcranial photobiomodulation.

干预措施: Transcranial infrared light stimulation (Device)

结局指标

主要结局

Autism spectrum questionnaires

时间窗: Up to two months

Assess individual differences and changes in autistic traits

次要结局

  • Functional near-infrared spectroscopy(Up to two months)
  • Continuous Performance Task(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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