Clinical trial NCT06203938: Autism Research Project With Non-Invasive Near-Infrared Light Stimulation
Official title: Social and Behavioral Associations With Prefrontal Photobiomodulation in Autism Spectrum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 280
Sex: ALL
Minimum age (years): 4
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed 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.

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.

Eligibility criteria: Inclusion Criteria:

* Age between 4-60 years

Exclusion Criteria:

* Current pregnancy

Primary outcomes:
measure: Autism spectrum questionnaires
timeFrame: Up to two months
Secondary outcomes:
measure: Functional near-infrared spectroscopy
timeFrame: Up to two months
measure: Continuous Performance Task
timeFrame: Up to two months
Other outcomes:
Locations:
city: Austin
country: United States
facility: Seay Psychology Building, Room 3.304
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Sarah W Diaz, PhD
role: STUDY_DIRECTOR
References: