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

Last updated: July 15, 2025
Sponsor: University of Texas at Austin
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism Spectrum Disorder (Asd)

Williams Syndrome

Autism

Treatment

Transcranial infrared light stimulation

Sham

Clinical Study ID

NCT06203938
STUDY00005301
  • Ages 4-60
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 4-60 years

Exclusion

Exclusion Criteria:

  • Current pregnancy

Study Design

Total Participants: 280
Treatment Group(s): 2
Primary Treatment: Transcranial infrared light stimulation
Phase:
Study Start date:
January 13, 2025
Estimated Completion Date:
December 31, 2027

Study Description

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.

Connect with a study center

  • Seay Psychology Building, Room 3.304

    Austin, Texas 78712
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.