- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06203938
Autism Research Project With Non-Invasive Near-Infrared Light Stimulation
Social and Behavioral Associations With Prefrontal Photobiomodulation in Autism Spectrum
Study Overview
Status
Conditions
Intervention / Treatment
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.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Francisco Gonzalez-Lima, PhD
- Phone Number: (512) 475-8497
- Email: UTAutismExperiment@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 4-60 years
Exclusion Criteria:
- Current pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Trancranial infrared light stimulation administered via light-emitting diodes
|
Sham Comparator: Sham
The sham control group undergoes the same procedure as the treatment group, but without the LEDs turned on.
|
Identical to TILS, but with lights off
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Autism spectrum questionnaires
Time Frame: Up to two months
|
Assess individual differences and changes in autistic traits
|
Up to two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Continuous Performance Task
Time Frame: Up to two months
|
Measure of inattention, impulsivity, sustained attention, vigilance
|
Up to two months
|
Functional near-infrared spectroscopy
Time Frame: Up to two months
|
Brain resting state and activational state measures
|
Up to two months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Douglas W Barrett, PhD, University of Texas at Austin
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00005301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorder
-
Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
-
Hoffmann-La RocheActive, not recruitingAutism Spectrum Disorder (ASD)United States, Canada, Italy, Spain
-
Axial Therapeutics, Inc.Active, not recruitingAutism Spectrum Disorder (ASD)United States, Australia, New Zealand
-
Technion, Israel Institute of TechnologyCompleted
-
Stanford UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedAutism | Autism Spectrum Disorder (ASD)United States
-
Corporacion Parc TauliUnknown
-
Institut de Recherches Internationales ServierADIR, a Servier Group companyTerminatedAutism Spectrum Disorder (ASD)Spain, United States, Hungary, Poland, Australia, United Kingdom, Brazil, Czechia, France, Italy, Portugal, Slovakia
-
Florida Gulf Coast UniversityCompletedAutism Spectrum Disorder High-FunctioningUnited States
-
Hospital Universitario Dr. Jose E. GonzalezUnknownAutism | Autism SpectrumMexico
-
National Taiwan University HospitalCompletedAutism Spectrum Disorder High-FunctioningTaiwan
Clinical Trials on Transcranial infrared light stimulation
-
Universidad de ValparaisoComisión Nacional de Investigación Científica y TecnológicaUnknownOpen Angle GlaucomaChile
-
University of FloridaParkinson's Foundation; FL DEPT OF HLTH ED ETHEL MOORE ALZHEIMERRecruiting
-
Riphah International UniversityRecruiting
-
East Bay Institute for Research and EducationCompletedDiabetic Neuropathy, Painful | Diabetic Polyneuropathy | Diabetic Neuralgia | Diabetic MononeuropathyUnited States
-
Boston UniversityBoston Medical CenterTerminated
-
China Medical University HospitalNot yet recruiting
-
Quietmind FoundationMaculume Ltd.Completed
-
University of Texas at AustinMilken Institute; Baszucki Brain Research FundNot yet recruiting
-
University of MiamiOffice of Naval Research (ONR)Completed
-
University College, LondonMoorfields Eye Hospital NHS Foundation TrustRecruiting