Photobiomodulation for Autism

(tPBM Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Richard E Frye, M.D., Ph.D

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Richard Frye

Must not be taking: Stimulants, Antipsychotics, Antihistamines

Disqualifiers: Self-abusive behavior, GERD, Genetic syndromes, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.

Will I have to stop taking my current medications?

The trial requires that participants keep their current treatments the same for the study period and for two months before starting. However, if you are taking stimulants, anti-psychotics, or antihistamines, you cannot participate in the trial.

What data supports the effectiveness of the treatment Transcranial Photobiomodulation (tPBM) for Autism?

Research shows that Transcranial Photobiomodulation (tPBM) can reduce autism symptoms, such as social and communication difficulties, in both adults and children. In a study with adults, 50% of participants showed significant improvement in social responsiveness, while a study with children showed reduced autism severity over six months. Additionally, animal studies suggest tPBM may help by reducing brain inflammation linked to autism. ^{1 2 3 4 5}

Is transcranial photobiomodulation (tPBM) safe for humans?

Research shows 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 it is considered a non-invasive treatment. ^{3 4 5 6 7}

How is the treatment tPBM for autism different from other treatments?

Transcranial photobiomodulation (tPBM) is unique because it uses non-invasive light therapy to stimulate brain activity, potentially improving brain metabolism and cognitive functions, unlike traditional treatments that may rely on medication or behavioral therapy. ^{7 8 9 10 11}

Research Team

Richard E Frye, M.D., Ph.D

Principal Investigator

Rossignol Medical Center, Phoenix AZ

Eligibility Criteria

This trial is for autistic children who may experience epileptiform activity. It's important that participants have a diagnosis of autism and are able to attend twice-weekly sessions for 10 weeks. Specific eligibility details aren't provided, but typically, trials like this would exclude those with certain medical conditions or taking conflicting treatments.

Inclusion Criteria

I can handle medical procedures well.

Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period

I am between 4 and 12 years old.

Exclusion Criteria

I have a diagnosed genetic syndrome.

Excessive hair that caregivers are unwilling or unable to manage

Congenital brain malformations

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial Photobiomodulation (tPBM) twice a week for 10 weeks

10 weeks

20 visits (in-person)

Assessment

Clinician completes CARS-2, SRS, CGI, and caregiver interview at baseline, 5 weeks, and end of study

Throughout treatment

3 assessment visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• tPBM (Photobiomodulation)

Trial Overview The study tests if a wearable device called Cognilum can help autistic children by delivering near infra-red light (tPBM) to the brain. The goal is to see if it improves focus, eye contact, speech, behavior, and functional skills over the course of treatment.

Participant Groups

Group I: Near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brain of autistic child Experimental Treatment 1 Intervention

This is a prospective, open level study comparing 15 individuals with active seizures and 15 individuals with EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) will be the active arm and the second arm will receive a placebo (no intervention).

Who Is Running the Clinical Trial?

Richard Frye

Lead Sponsor

Trials

2

Recruited

1,000+

Findings from Research

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]

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]

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]

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]

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]

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]

Chronic transcranial photobiomodulation using a specific laser treatment (810 nm wavelength at 100 mW) for 58 days significantly enhanced neuronal growth in the cerebral cortex of rats.

The treatment led to an increase in the number of dendritic nodes and ends, indicating neuroplasticity, while also reducing the total dendritic length, suggesting a reorganization of neuronal structure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial photobiomodulation changes neuronal morphology in the cerebral cortex of rats. Cardoso, FDS., Serra, FT., Coimbra, NC., et al.[2022]

Transcranial photobiomodulation (tPBM) showed promising effects in improving frontal lobe cognitive functions in three older adults with mild cognitive impairment (MCI) after 18 sessions over 9 weeks, with significant improvements in memory tests for all participants.

In addition to cognitive improvements, tPBM also led to reductions in anxiety and depressive symptoms, with one participant moving from severe to mild symptoms and others achieving normal levels, suggesting potential mental health benefits alongside cognitive enhancement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation improves frontal lobe cognitive functions and mental health of older adults with non-amnestic mild cognitive impairment: Case studies. Cheung, MC., Lee, TL., Sze, SL., et al.[2023]

Transcranial photobiomodulation (tPBM) significantly enhances the metabolic and hemodynamic activities in the prefrontal cortex, with effects varying by wavelength (800 or 850 nm) and the specific site of application on the forehead, as demonstrated in a study involving 26 healthy young adults.

The study found that tPBM increased metabolic-hemodynamic coupling and altered the coherence of neurophysiological networks, indicating that tPBM can effectively modulate brain activity in a targeted manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Site-specific effects of 800- and 850-nm forehead transcranial photobiomodulation on prefrontal bilateral connectivity and unilateral coupling in young adults. Shahdadian, S., Wang, X., Kang, S., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Efficacy of Laser Acupuncture for Children With Autism Spectrum Disorder: Clinical, Molecular, and Biochemical Study. [2023]

3. 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]

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

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

Photobiomodulation Attenuated Cognitive Dysfunction and Neuroinflammation in a Prenatal Valproic Acid-Induced Autism Spectrum Disorder Mouse Model. [2022]

6. 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]

7. Scotland pubmed.ncbi.nlm.nih.gov

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

8. Ireland pubmed.ncbi.nlm.nih.gov

Transcranial photobiomodulation changes neuronal morphology in the cerebral cortex of rats. [2022]

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

Transcranial Photobiomodulation (tPBM) With 1,064-nm Laser to Improve Cerebral Metabolism of the Human Brain In Vivo. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Photobiomodulation improves frontal lobe cognitive functions and mental health of older adults with non-amnestic mild cognitive impairment: Case studies. [2023]

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

Site-specific effects of 800- and 850-nm forehead transcranial photobiomodulation on prefrontal bilateral connectivity and unilateral coupling in young adults. [2023]