Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06203938 |
| Other study ID # |
STUDY00005301 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2024 |
| Est. completion date |
December 2027 |
Study information
| Verified date |
January 2024 |
| Source |
University of Texas at Austin |
| Contact |
Francisco Gonzalez-Lima, PhD |
| Phone |
(512) 475-8497 |
| Email |
UTAutismExperiment[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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).
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.
