Infrared Light Therapy for Autism

Overseen By Francisco Gonzalez-Lima, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether low-level infrared light therapy (Transcranial Infrared Light Stimulation) can improve behavior in people with autism spectrum disorder (ASD). Researchers believe this safe, non-invasive treatment might enhance brain activity and improve cognition and emotions. Participants will receive either the actual light therapy or a sham treatment, where the lights remain off, for comparison. This trial may suit individuals diagnosed with autism who are interested in non-invasive treatment options. As an unphased trial, it offers a unique opportunity to explore innovative, non-invasive treatments for autism.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this methodology is safe for individuals with autism spectrum disorder?

Research has shown that transcranial infrared light stimulation (TILS) is safe and generally well-tolerated. Studies involving children and adults with autism spectrum disorder (ASD) have produced encouraging results. Specifically, one study found that TILS might be safe and helpful for young children with ASD. Another study with adults indicated that TILS could be a safe and practical way to address core ASD symptoms, such as difficulties with social interaction.

No major reports of serious side effects have emerged, suggesting that TILS is usually well-tolerated. This therapy is non-invasive, meaning it doesn't involve surgery or entering the body. It uses light-emitting diodes (LEDs) to deliver the treatment, which contributes to its safety. Overall, TILS appears to be a promising and safe option for helping with ASD symptoms, but more research is needed to fully understand its effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcranial Infrared Light Stimulation (TILS) for autism because it offers a novel, non-invasive approach using light-emitting diodes (LEDs). Unlike traditional treatments, such as behavioral therapy or medications that can have side effects, TILS harnesses infrared light to potentially modulate brain activity without direct intervention. This method, known as photobiomodulation, could provide a safer alternative by stimulating brain regions involved in social behavior and cognition. The hope is that TILS might offer a new way to address core symptoms of autism more gently and effectively.

What evidence suggests that transcranial infrared light stimulation is effective for autism?

Research has shown that transcranial infrared light, also known as photobiomodulation, might help reduce symptoms of autism spectrum disorder (ASD). In this trial, participants in the TILS-treated arm will receive transcranial infrared light stimulation through light-emitting diodes (LEDs). One study found that this treatment decreased autism severity, as indicated by lower scores on a scale measuring ASD behaviors. Other research supports its potential as a safe and effective method to improve ASD symptoms and suggests further study. Additionally, this approach has been linked to better brain function and emotional control. Overall, transcranial infrared light therapy appears promising as a non-invasive way to manage ASD symptoms. ^{2 4 6 7 8}

Who Is on the Research Team?

Sarah W Diaz, PhD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for individuals aged between 4 to 60 years who have been diagnosed with Autism Spectrum Disorder. It's not suitable for those outside this age range or without an ASD diagnosis.

Inclusion Criteria

I am between 4 and 60 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Baseline Assessment

Participants are trained on using the LED device and complete baseline questionnaires and cognitive tests

1 week

1 visit (in-person)

Treatment

Participants use the TILS device at home with weekly check-ins by investigators

8 weeks

8 visits (virtual)

Follow-up

Participants return for final assessments and return the LED device

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Infrared Light Stimulation

Trial Overview The study tests the effects of Transcranial infrared light stimulation, a non-invasive procedure thought to improve cognition and emotional well-being in people with autism, against a sham (placebo) treatment.

How Is the Trial Designed?

Group I: TILS-treated Experimental Treatment 1 Intervention

Transcranial infrared light stimulation (TILS) will be administered via light-emitting diodes (LEDs), which are a safe and non-invasive form of transcranial photobiomodulation.

Group II: Sham Placebo Group 1 Intervention

The sham control group undergoes the same procedure as the treatment group, but without the LEDs turned on.

Transcranial Infrared Light Stimulation is already approved in United States for the following indications:

Approved in United States as Transcranial Photobiomodulation for:

• Autism Spectrum Disorder (ASD)

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Published Research Related to This Trial

Transcranial photobiomodulation (t-PBM) is a safe and potentially effective novel therapy for major depressive disorder (MDD), as indicated by a review of 19 studies (9 clinical and 10 preclinical).

t-PBM works by stimulating mitochondrial activity, which increases cellular energy metabolism, but varying treatment parameters across studies make it difficult to draw definitive conclusions about its overall efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation for Major Depressive Disorder: Linking Transcranial Infrared Light, Biophotons and Oxidative Stress. Vieira, WF., Gersten, M., Caldieraro, MAK., et al.[2023]

In a study involving 49 participants with major depressive disorder (MDD), transcranial photobiomodulation (t-PBM) using low irradiance and low energy did not show significant efficacy compared to sham treatment, indicating that the current dosing may be insufficient for therapeutic effects.

The results suggest that a minimal dose threshold is necessary for t-PBM to be effective in treating MDD, similar to other neuromodulation techniques, highlighting the need for further research to determine optimal dosing parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very Low-Level Transcranial Photobiomodulation for Major Depressive Disorder: The ELATED-3 Multicenter, Randomized, Sham-Controlled Trial. Iosifescu, DV., Norton, RJ., Tural, U., et al.[2022]

Photobiomodulation (PBM) uses red or near-infrared light to potentially heal and protect brain tissue affected by various disorders, including traumatic injuries, degenerative diseases, and psychiatric conditions.

Recent advancements, such as affordable LED light-emitting helmets, have made it easier to apply PBM to the brain, showing promise for cognitive enhancement and treatment of brain disorders based on pre-clinical and clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shining light on the head: Photobiomodulation for brain disorders. Hamblin, MR.[2020]

Transcranial photobiomodulation (tPBM) over six months significantly reduced the severity of Autism Spectrum Disorder (ASD) symptoms in 21 children, as indicated by lower scores on the Childhood Autism Rating Scale (CARS).

The treatment also led to improvements in noncompliant behaviors, parental stress, cognitive rigidity, attention functions, and sleep quality, suggesting that tPBM may be a promising non-pharmacological intervention for managing ASD challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Photobiomodulation for the Treatment of Children with Autism Spectrum Disorder (ASD): A Retrospective Study. Pallanti, S., Di Ponzio, M., Grassi, E., et al.[2023]

Transcranial photobiomodulation (tPBM) is a safe and non-invasive treatment that effectively enhances higher electrophysiological oscillations in the brain, based on a review of 10 studies involving healthy individuals aged 18-80.

While tPBM shows promise in improving brain activity, the evidence regarding its effects on lower oscillatory frequencies remains inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcranial photobiomodulation on electrophysiological activity of brain in healthy individuals: A scoping review. Shetty, SJ., Shetty, S., Shettigar, D., et al.[2023]

Photobiomodulation, which uses red to near-infrared light, shows promise as a potential treatment for autism by improving brain connectivity, reducing inflammation, and positively affecting the gut microbiome.

This mini-review suggests that photobiomodulation could address key abnormalities associated with autism, making it a treatment option that deserves more research and exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lights on for Autism: Exploring Photobiomodulation as an Effective Therapeutic Option. Hamilton, C., Liebert, A., Pang, V., et al.[2022]

Transcranial photobiomodulation (tPBM) was found to be a safe and feasible treatment for adults with high-functioning autism spectrum disorder (ASD), with 50% of participants showing significant improvement in symptoms after 8 weeks of treatment.

Participants experienced a notable reduction in ASD symptom severity, particularly in areas like social awareness and communication, along with improvements in overall functioning and quality of life, while only mild side effects were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Photobiomodulation in Adults with High-Functioning Autism Spectrum Disorder: Positive Findings from a Proof-of-Concept Study. Ceranoglu, TA., Cassano, P., Hoskova, B., et al.[2022]

Photobiomodulation (PBM) therapy enhances neuronal metabolism and promotes beneficial processes like synaptogenesis and neurogenesis, making it a promising treatment for depression and other neurological conditions such as Parkinson's disease and dementia.

The effectiveness of PBM therapy relies on optimal light dosage, which can be challenging due to light attenuation in tissue; therefore, innovative delivery methods like intranasal and intracranial systems are being explored to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain photobiomodulation therapy on neurological and psychological diseases. Chamkouri, H., Liu, Q., Zhang, Y., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9139753/

Transcranial Photobiomodulation for the Treatment of ... Findings show that tPBM was associated with a reduction in ASD severity, as shown by a decrease in CARS scores during the intervention.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04569058

NCT04569058 | Transcranial Photobiomodulation Therapy ... An open label trial to assess the safety and efficacy of transcranial photobiomodulation (tPBM) in improving autistic traits in ADHD youth. Detailed Description.

3. frontiersin.org frontiersin.org/journals/child-and-adolescent-psychiatry/articles/10.3389/frcha.2025.1477839/full

Transcranial photobiomodulation for reducing symptoms of ... This study supports the potential of tPBM as a safe and effective treatment for ASD, and it suggests that EEG measurements may serve as a useful biomarker for ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38737349/

Transcranial photobiomodulation in children aged 2-6 years These results indicate that tPBM may be a safe and effective treatment for ASD and should be studied in more depth in larger studies.

5. liebertpub.com liebertpub.com/doi/10.1089/photob.2020.4986

Transcranial Photobiomodulation in Adults with High- ... Objective: To assess the efficacy and safety of transcranial photobiomodulation (tPBM) in adults with autism spectrum disorder (ASD).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11086174/

Transcranial photobiomodulation in children aged 2–6 years These results indicate that tPBM may be a safe and effective treatment for ASD and should be studied in more depth in larger studies.

7. mghpsychnews.org mghpsychnews.org/transcranial-photobiomodulation-for-adults-with-autism-spectrum-disorder/

Transcranial Photobiomodulation for Adults with Autism ... This pilot study indicates that tPBM is a safe and feasible treatment approach with the potential to treat core features of ASD, including deficits in social ...

8. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/photobiomodulation

Near Infrared Light Therapy for the Treatment of Autistic Traits ... Transcranial Photobiomodulation may be a promising, feasible, safe, and non-invasive treatment approach for the symptoms associated with ASD. With this study, ...