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

Social and Behavioral Associations With Prefrontal Photobiomodulation in Autism Spectrum

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06203938
Enrollment
280
Registered
2024-01-12
Start date
2025-01-13
Completion date
2027-12-01
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Brief 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).

Detailed 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.

Interventions

DEVICETranscranial infrared light stimulation

Trancranial infrared light stimulation administered via light-emitting diodes

DEVICESham

Identical to TILS, but with lights off

Sponsors

Francisco Gonzalez-Lima, PhD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

The investigators propose to study the effects of non-invasive transcranial infrared light stimulation (TILS) on individuals with ASD using cognitive testing, questionnaires, and non-invasive near-infrared spectroscopy (NIRS). Participants will have the brain activity monitored by NIRS before and after TILS. Cognitive testing and questionnaires before and after TILS will measure beneficial effects of TILS on cognition and ASD symptoms. TILS will be administered with light-emitting diodes (LEDs), which have general FDA clearance as safe for use in humans.

Eligibility

Sex/Gender
ALL
Age
4 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Age between 4-60 years

Exclusion criteria

* Current pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Autism spectrum questionnairesUp to two monthsAssess individual differences and changes in autistic traits

Secondary

MeasureTime frameDescription
Functional near-infrared spectroscopyUp to two monthsBrain resting state and activational state measures
Continuous Performance TaskUp to two monthsMeasure of inattention, impulsivity, sustained attention, vigilance

Countries

United States

Contacts

CONTACTFrancisco Gonzalez-Lima, PhD
UTAutismExperiment@gmail.com512-537-5257
STUDY_DIRECTORSarah W Diaz, PhD

University of Texas at Austin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026