tPBM for Autism

Overseen By Chloe Hutt Vater, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Psychotropic, Light-activated drugs

Disqualifiers: Impaired intellectual capacity, Unstable psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called transcranial photobiomodulation (tPBM), which uses near-infrared light on the brain, to determine its effectiveness for adults with autism spectrum disorder (ASD). The study compares tPBM to a placebo treatment to assess its effectiveness and safety. Adults with moderate to severe ASD symptoms who can communicate well enough to participate might be suitable candidates. Participants should not have unstable medical or psychiatric conditions. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in ASD treatment.

Will I have to stop taking my current medications?

The trial requires that if you are taking psychotropic medications, your dose must be stable for at least 4 weeks before starting the study. If your medication dose is not stable, you may need to adjust it before participating.

What prior data suggests that transcranial photobiomodulation (tPBM) is safe for adults with ASD?

Research has shown that using light therapy on the brain, known as transcranial photobiomodulation (tPBM), is generally safe for treating autism. In past studies, both children and adults with autism spectrum disorder (ASD) tolerated this treatment well. The findings suggest that tPBM does not cause major side effects and could help with key symptoms of ASD. However, more research is needed to confirm these safety results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for autism, which often involve behavioral therapies or medications targeting symptoms, transcranial photobiomodulation (tPBM) uses near-infrared light applied to the brain. This noninvasive technique is exciting to researchers because it may stimulate brain activity and improve neurological function without the need for drugs. By potentially enhancing communication and social skills through this novel light-based approach, tPBM offers a fresh avenue of hope for those seeking alternatives to conventional autism therapies.

What evidence suggests that transcranial photobiomodulation (tPBM) is effective for autism?

Research has shown that transcranial photobiomodulation (tPBM), a treatment that participants in this trial may receive, might help reduce symptoms of autism spectrum disorder (ASD). One study reported a noticeable 7-point drop in participants' CARS-2 scores, which measure autism severity. Other research also indicates a decrease in ASD severity with tPBM. These findings suggest that tPBM could be an effective treatment for ASD, but further studies are needed to fully understand its potential. ^{1 6 7 8 9}

Who Is on the Research Team?

T. Atilla Ceranoglu, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

Adults aged 18-59 with Autism Spectrum Disorder (ASD) who can understand the study and give informed consent are eligible. They should not have intellectual disabilities, unstable psychiatric conditions, or serious safety risks. Women must use double-barrier contraception if applicable.

Inclusion Criteria

Participant experiencing a major psychiatric disorder will be allowed to participate in the study provided they do not meet any exclusionary criteria

I am using two forms of birth control if I can have children and am sexually active.

You can participate in the study if you have a psychiatric disorder, as long as it doesn't prevent you from meeting other criteria.

Exclusion Criteria

I have a skin condition like a rash or tattoo where the procedure will be done.

I can communicate, take care of myself, have worked or completed high school without a history of intellectual disability.

My mental health medication dose has been stable for less than 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial photobiomodulation (tPBM) or sham treatment for 8 weeks to assess efficacy, safety, and tolerability in ASD

8 weeks

Multiple sessions at home with scheduled safety monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo/ Sham
• Transcranial Photobiomodulation (tPBM)

Trial Overview

The trial is testing Transcranial Photobiomodulation (tPBM), a light therapy on the brain, against a placebo to see if it's safe and effective for treating ASD symptoms over an 8-week period in a randomized controlled setting.

How Is the Trial Designed?

Group I: Transcranial Photobiomodulation (tPBM) Treatment Active Control 1 Intervention

Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light is applied to forebrain.

Group II: Placebo/ Sham Treatment Placebo Group 1 Intervention

The sham treatment will mimic the tPBM procedure, while delivering no light.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Photobiomodulation (PBM) treatment in a mouse model of autism spectrum disorder (ASD) significantly reduced behavioral and histological changes associated with the condition, suggesting its potential as a therapeutic intervention.

PBM treatment also decreased neuroinflammation, as indicated by reduced activation of microglia and astrocytes, which may help counteract the underlying mechanisms of ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation Attenuated Cognitive Dysfunction and Neuroinflammation in a Prenatal Valproic Acid-Induced Autism Spectrum Disorder Mouse Model. Kim, UJ., Hong, N., Ahn, JC.[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]

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]

Transcranial photobiomodulation (tPBM) is a safe and feasible treatment for Parkinson's disease, with only minor, temporary adverse events reported during a 12-week trial involving 20 participants.

While tPBM showed promise in reducing motor symptoms, there was no significant difference in motor scores between the active and sham treatment groups, indicating that further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel transcranial photobiomodulation device to address motor signs of Parkinson's disease: a parallel randomised feasibility study. Herkes, G., McGee, C., Liebert, A., et al.[2023]

Low-level laser acupuncture (LLLA) therapy significantly improved the severity of autism spectrum disorder (ASD) symptoms and language abilities in children, with a notable difference in improvement compared to the control group (P = 0.002; 0.03).

LLLA therapy also led to a significant reduction in plasma BDNF levels in the treatment group (P < 0.001), suggesting a potential mechanism of action, while miR-320 expression did not change, indicating its diagnostic value in distinguishing children with ASD from neurotypical peers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Laser Acupuncture for Children With Autism Spectrum Disorder: Clinical, Molecular, and Biochemical Study. Elsheikh, MS., Ashaat, EA., Ramadan, A., et al.[2023]

In a study involving 13 patients with autism and 13 controls, low frequency repetitive transcranial magnetic stimulation (rTMS) was applied twice a week for 3 weeks, leading to significant improvements in event-related potentials and behavioral measures.

The findings suggest that rTMS may enhance the inhibitory function of minicolumns in the brain, indicating its potential as a therapeutic intervention for autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of low frequency repetitive transcranial magnetic stimulation (rTMS) on gamma frequency oscillations and event-related potentials during processing of illusory figures in autism. Sokhadze, EM., El-Baz, A., Baruth, J., 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]

Citations

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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.

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pubmed.ncbi.nlm.nih.gov

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

Transcranial photobiomodulation in children aged 2-6 years

Conclusion: These results indicate that tPBM may be a safe and effective treatment for ASD and should be studied in more depth in larger studies.Clinical trial ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05363982

Evaluation of Transcranial Photobiomodulation in Autism ...

The purpose of this 8-week double-blind randomized placebo-controlled study is to assess the tolerability, safety, and efficacy of tPBM in adult patients with ...

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frontiersin.org

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

Transcranial photobiomodulation for reducing symptoms of ...

Results: The intervention resulted in a significant 7-point reduction in average CARS-2 scores (t = 10.23, p < .0001), along with decreased ...

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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.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34941429/

Positive Findings from a Proof-of-Concept Study

tPBM is a safe and feasible treatment approach that has the potential to treat core features of ASD. Further research is necessary and warranted.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05363982

Evaluation of Transcranial Photobiomodulation in Autism ...

The purpose of this 8-week double-blind randomized placebo-controlled study is to assess the tolerability, safety, and efficacy of tPBM in adult patients with ...

8.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1221193/full

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.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT03724552

Photobiomodulation in Autism Spectrum Disorder (ASD)

The purpose of this 8-week open-label study is to assess the tolerability, safety, and efficacy of Transcranial LED Therapy in patients with Autism Spectrum ...