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NCT Number: NCT06203938

Autism Research Project With Non-Invasive Near-Infrared Light Stimulation

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).

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Key information

Age range

4 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seay Psychology Building, Room 3.304

Austin, Texas, 78712, United States

Location status: Recruiting

Location contact

Sarah Diaz

CONTACT

[email protected]

(512) 956-6338‬

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 4-60 years

Exclusion criteria

  • Current pregnancy

Treatment and study plan

Transcranial infrared light stimulation

Device

Trancranial infrared light stimulation administered via light-emitting diodes

SHAM

Device

Identical to TILS, but with lights off

Primary outcomes

  1. Autism spectrum questionnaires

    Time frame: Up to two months

    Assess individual differences and changes in autistic traits

Secondary outcomes

  1. Functional near-infrared spectroscopy

    Time frame: Up to two months

    Brain resting state and activational state measures

  2. Continuous Performance Task

    Time frame: Up to two months

    Measure of inattention, impulsivity, sustained attention, vigilance

Study contacts

Contact information is provided by the study sponsor or research team.

Francisco Gonzalez-Lima, PhD

CONTACT

[email protected]

512-537-5257

Sponsors and collaborators

Lead sponsor

Francisco Gonzalez-Lima, PhD

Other

Registry information

Official study title

Social and Behavioral Associations With Prefrontal Photobiomodulation in Autism Spectrum

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 12, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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