Autism Research Project With Non-Invasive Near-Infrared Light Stimulation
NCT ID: NCT06203938
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
280 participants
INTERVENTIONAL
2025-01-13
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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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.
Transcranial infrared light stimulation
Trancranial infrared light stimulation administered via light-emitting diodes
Sham
The sham control group undergoes the same procedure as the treatment group, but without the LEDs turned on.
Sham
Identical to TILS, but with lights off
Interventions
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Transcranial infrared light stimulation
Trancranial infrared light stimulation administered via light-emitting diodes
Sham
Identical to TILS, but with lights off
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
4 Years
60 Years
ALL
No
Sponsors
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University of Texas at Austin
OTHER
Responsible Party
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Francisco Gonzalez-Lima, PhD
Professor
Principal Investigators
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Sarah W Diaz, PhD
Role: STUDY_DIRECTOR
University of Texas at Austin
Locations
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Seay Psychology Building, Room 3.304
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00005301
Identifier Type: -
Identifier Source: org_study_id
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