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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Not yet enrolling

Conditions

Autism Spectrum Disorder

Treatments

Device: Sham
Device: Transcranial infrared light stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06203938
STUDY00005301

Details and patient eligibility

About

We 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, we 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).

Full 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. Our 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 our 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. We will train participants (or their caregivers) on how to use the LED device, then send them home to use the LED device. We will contact participants once a week to check their progress. At the end of the study, participants return for the same assessments, at which time they will return the LED device.

Enrollment

280 estimated patients

Sex

All

Ages

4 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 4-60 years

Exclusion criteria

  • Current pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

280 participants in 2 patient groups

TILS-treated
Experimental group
Description:
Transcranial infrared light stimulation (TILS) will be administered via light-emitting diodes (LEDs), which are a safe and non-invasive form of transcranial photobiomodulation.
Treatment:
Device: Transcranial infrared light stimulation
Sham
Sham Comparator group
Description:
The sham control group undergoes the same procedure as the treatment group, but without the LEDs turned on.
Treatment:
Device: Sham

Trial contacts and locations

0

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Central trial contact

Francisco Gonzalez-Lima, PhD

Data sourced from clinicaltrials.gov

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