Recruiting

Near-Infrared Light Stimulation

Sponsor:

Francisco Gonzalez-Lima, PhD

Code:

NCT06203938

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 4 - 60

Healthy Volunteers: Not accepted

Interventions

Transcranial infrared light stimulation

Sham

Study Details

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).

Conditions

Autism Spectrum Disorder

Study ID

NCT06203938

Start date

Jan 13, 2025

Status verified date

Jul, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age between 4-60 years

Exclusion Criteria:

  • Current pregnancy

Study Design

Enrollment

280 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

sham comparator: Sham

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

Interventions

Transcranial infrared light stimulation

Trancranial infrared light stimulation administered via light-emitting diodes

Sham

Identical to TILS, but with lights off

Primary outcome measure

  • Autism spectrum questionnaires [ Time Frame: Up to two months ]

Central Contacts and Locations

Central contacts

Francisco Gonzalez-Lima, PhD

512-537-5257UTAutismExperiment@gmail.com

Locations

Seay Psychology Building, Room 3.304

Recruiting

Austin, Texas, United States, 78712

Contacts

Sarah Diaz

(512) 956-6338‬UTAutismExperiment@gmail.com

More Information

Sponsor

Francisco Gonzalez-Lima, PhD

Last update posted

Jun 22, 2026

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Francisco Gonzalez-Lima, PhD on 2026-06-22.