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

Trial Summary

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 data supports the effectiveness of the treatment Transcranial Infrared Light Stimulation for Autism?

Research shows that transcranial photobiomodulation (tPBM) can reduce autism symptoms, with studies reporting improvements in social communication and behavior in both adults and children with autism. Additionally, tPBM has shown potential benefits in other conditions like major depressive disorder, suggesting it may help improve brain function and mood. ^{1 2 3 4 5}

Is transcranial photobiomodulation (tPBM) safe for humans?

Transcranial photobiomodulation (tPBM) is generally considered safe for humans. In studies involving adults and children with autism, as well as healthy individuals, tPBM was associated with only mild and temporary side effects like insomnia, headache, and warmth at the treatment site, with no serious adverse events reported. ^{1 2 3 6 7}

How does transcranial infrared light stimulation differ from other treatments for autism?

Transcranial infrared light stimulation (tPBM) is unique because it uses near-infrared light applied to the head to stimulate brain activity, which is a non-invasive and drug-free approach. Unlike other treatments, it specifically targets neural tissues to potentially improve social and communication skills in individuals with autism, and there are currently no standard pharmacological treatments for the core features of autism. ^{1 2 3 6 8}

What is the purpose of this trial?

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).

Research Team

Sarah W Diaz, PhD

Principal Investigator

University of Texas at Austin

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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, 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 (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]

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 (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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transcranial Photobiomodulation in Adults with High-Functioning Autism Spectrum Disorder: Positive Findings from a Proof-of-Concept Study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Transcranial Photobiomodulation for the Treatment of Children with Autism Spectrum Disorder (ASD): A Retrospective Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Very Low-Level Transcranial Photobiomodulation for Major Depressive Disorder: The ELATED-3 Multicenter, Randomized, Sham-Controlled Trial. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Lights on for Autism: Exploring Photobiomodulation as an Effective Therapeutic Option. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Photobiomodulation for Major Depressive Disorder: Linking Transcranial Infrared Light, Biophotons and Oxidative Stress. [2023]

6. Scotland pubmed.ncbi.nlm.nih.gov

Effect of transcranial photobiomodulation on electrophysiological activity of brain in healthy individuals: A scoping review. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Brain photobiomodulation therapy on neurological and psychological diseases. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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