41 Participants Needed

tPBM for Autism

CH
Overseen ByChloe Hutt Vater, BA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing a new light-based treatment called tPBM for adults with Autism Spectrum Disorder (ASD). The treatment aims to improve brain function by increasing energy production in brain cells. The study will evaluate if this treatment is safe and effective for reducing ASD symptoms.

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 data supports the effectiveness of the treatment tPBM for Autism?

Research shows that transcranial photobiomodulation (tPBM) can reduce autism symptoms, such as social communication difficulties and repetitive behaviors, in both adults and children with autism spectrum disorder (ASD). Studies also suggest that tPBM may improve overall functioning and quality of life in individuals with ASD.12345

Is transcranial photobiomodulation (tPBM) safe for humans?

Research indicates that transcranial photobiomodulation (tPBM) is generally safe for humans, with only mild side effects like insomnia, headache, and warmth at the treatment site reported in some cases. No serious adverse events have been noted, and no changes in treatment protocols were required due to side effects.23467

How does transcranial photobiomodulation (tPBM) treatment for autism differ from other treatments?

Transcranial photobiomodulation (tPBM) is a unique treatment for autism because it uses light to stimulate brain activity, which is different from traditional drug therapies. It is non-invasive and focuses on improving social and communication skills by targeting neural tissues, offering a novel approach where no standard pharmacological treatments exist for core autism features.23489

Research Team

TA

T. Atilla Ceranoglu, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.
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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.
See 8 more

Timeline

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

Treatment Details

Interventions

  • Placebo/ Sham
  • Transcranial Photobiomodulation (tPBM)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Transcranial Photobiomodulation (tPBM) TreatmentActive Control1 Intervention
Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light is applied to forebrain.
Group II: Placebo/ Sham TreatmentPlacebo Group1 Intervention
The sham treatment will mimic the tPBM procedure, while delivering no light.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Findings from Research

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.
Efficacy of Laser Acupuncture for Children With Autism Spectrum Disorder: Clinical, Molecular, and Biochemical Study.Elsheikh, MS., Ashaat, EA., Ramadan, A., et al.[2023]
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.
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) 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.
Photobiomodulation Attenuated Cognitive Dysfunction and Neuroinflammation in a Prenatal Valproic Acid-Induced Autism Spectrum Disorder Mouse Model.Kim, UJ., Hong, N., Ahn, JC.[2022]

References

Efficacy of Laser Acupuncture for Children With Autism Spectrum Disorder: Clinical, Molecular, and Biochemical Study. [2023]
Transcranial Photobiomodulation in Adults with High-Functioning Autism Spectrum Disorder: Positive Findings from a Proof-of-Concept Study. [2022]
Photobiomodulation Attenuated Cognitive Dysfunction and Neuroinflammation in a Prenatal Valproic Acid-Induced Autism Spectrum Disorder Mouse Model. [2022]
Transcranial Photobiomodulation for the Treatment of Children with Autism Spectrum Disorder (ASD): A Retrospective Study. [2023]
Effects of low frequency repetitive transcranial magnetic stimulation (rTMS) on gamma frequency oscillations and event-related potentials during processing of illusory figures in autism. [2022]
A novel transcranial photobiomodulation device to address motor signs of Parkinson's disease: a parallel randomised feasibility study. [2023]
Very Low-Level Transcranial Photobiomodulation for Major Depressive Disorder: The ELATED-3 Multicenter, Randomized, Sham-Controlled Trial. [2022]
Effect of transcranial photobiomodulation on electrophysiological activity of brain in healthy individuals: A scoping review. [2023]
Differential effects of photobiomodulation interval schedules on brain cytochrome c-oxidase and proto-oncogene expression. [2020]