NCT06203938

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
18mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

January 2, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

January 13, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

2.9 years

First QC Date

January 2, 2024

Last Update Submit

July 15, 2025

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • Autism spectrum questionnaires

    Assess individual differences and changes in autistic traits

    Up to two months

Secondary Outcomes (2)

  • Functional near-infrared spectroscopy

    Up to two months

  • Continuous Performance Task

    Up to two months

Study Arms (2)

TILS-treated

EXPERIMENTAL

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

Sham

SHAM COMPARATOR

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

Device: Sham

Interventions

Transcranial infrared light stimulationDEVICE

Trancranial infrared light stimulation administered via light-emitting diodes

TILS-treated
ShamDEVICE

Identical to TILS, but with lights off

Sham

Eligibility Criteria

Age4 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age between 4-60 years

You may not qualify if:

  • Current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seay Psychology Building, Room 3.304

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sarah W Diaz, PhD

    University of Texas at Austin

    STUDY DIRECTOR

Central Study Contacts

Francisco Gonzalez-Lima, PhD

CONTACT

512-537-5257UTAutismExperiment@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 12, 2024

Study Start

January 13, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending 36 months following article publication.
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.
More information

Locations

US(1)