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

Social and Behavioral Associations With Prefrontal Photobiomodulation in Autism Spectrum

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).

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: Transcranial infrared light stimulation; Device: Sham

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.

• Study Type: Interventional
• Enrollment (Estimated): 280
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francisco Gonzalez-Lima, PhD; Phone Number: 512-537-5257; Email: UTAutismExperiment@gmail.com

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • Seay Psychology Building, Room 3.304
      • Contact: Sarah Diaz; Phone Number: (512) 956-6338‬; Email: UTAutismExperiment@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 4-60 years

Exclusion Criteria:

• Current pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TILS-treated; Transcranial infrared light stimulation (TILS) will be administered via light-emitting diodes (LEDs), which are a safe and non-invasive form of transcranial photobiomodulation.	Device: Transcranial infrared light stimulation; Trancranial infrared light stimulation administered via light-emitting diodes
Sham Comparator: Sham; The sham control group undergoes the same procedure as the treatment group, but without the LEDs turned on.	Device: Sham; Identical to TILS, but with lights off

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autism spectrum questionnaires	Assess individual differences and changes in autistic traits	Up to two months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Performance Task	Measure of inattention, impulsivity, sustained attention, vigilance	Up to two months
Functional near-infrared spectroscopy	Brain resting state and activational state measures	Up to two months

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Study Director: Sarah W Diaz, PhD, University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Autistic Disorder
• Other Study ID Numbers: STUDY00005301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

What data will be shared? Individual participant data that underlie the results reported in this study, after deidentification (text, tables, figures, and appendices).

A data dictionary, including a description of the variables and types of data, collected for each individual, will be provided. This data will include anonymized individual participant demographic information and all outcome variables (cognitive task data, spectroscopy data).

• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

The raw data will be made available by the researchers upon reasonable request by any qualified doctoral researcher (PhD, MD). They will be granted access by contacting the corresponding author/principal investigator (F. Gonzalez-Lima, utbrainproject@gmail.com).

It will be made available to qualified researchers whose proposed use of the data has been approved by an independent review committee (Institutional Review Board) identified for the purpose of individual participant data meta-analysis.

Proposals may be submitted up to 36 months following article publication. After 36 months, the data will be available in our University's shared network drive, but without investigator support other than deposited metadata.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No