Photobiomodulation for Autism

(tPBM Trial)

Overseen By Kelly Sirju

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Richard Frye

Must not be taking: Stimulants, Antipsychotics, Antihistamines

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

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 24

Duration: 10 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using near-infrared light delivered through a wearable device called Cognilum. The treatment aims to improve focus, eye contact, speech, behavior, and functional skills in children with autism. The trial targets children with autism who have been managing their condition with stable treatments and can handle the trial procedures. Participants will receive light therapy, known as transcranial photobiomodulation (tPBM), to specific brain areas twice a week for 10 weeks. Some children will receive the actual treatment, while others will not, to determine if there are noticeable improvements. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

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 prior data suggests that the Cognilum device is safe for autistic children?

Research shows that transcranial photobiomodulation (tPBM) might be safe for children with autism. Earlier studies used tPBM on children as young as 2 years old, and the results suggest it could be both safe and helpful. Most children handled it well, with only a few side effects reported. Another study on tPBM for autism also supported its safety, noting that patients generally tolerated the treatment well. While more research is needed, current evidence provides some confidence in the safety of tPBM for treating autism. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for autism?

Unlike the standard treatments for autism, which often involve medication and behavioral therapy, transcranial Photobiomodulation (tPBM) uses near infra-red (NIR) light to directly target the brain. This approach is unique because it aims to improve brain function by stimulating cells with light, potentially offering a non-invasive and drug-free alternative. Researchers are excited about tPBM because it could provide benefits for individuals with autism, especially those with active seizures or EEG abnormalities, by enhancing brain activity in a novel way.

What evidence suggests that transcranial Photobiomodulation might be an effective treatment for autism?

Research has shown that transcranial photobiomodulation (tPBM), a treatment using near-infrared light, may help improve symptoms in children with autism. In this trial, one group will receive tPBM, while the other will receive a placebo (no intervention). Studies have found that tPBM is safe and can effectively reduce symptoms like difficulty focusing and lack of eye contact. One study reported noticeable improvements in traits associated with autism. Another study highlighted the potential for tPBM to enhance overall behavior and skills in young children with autism. These findings suggest that tPBM could be a promising treatment option worth further exploration. ^{1 3 6 7 8}

Who Is on the Research Team?

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

Principal Investigator

Rossignol Medical Center, Phoenix AZ

Are You a Good Fit for This Trial?

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

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) 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)

What Are the Treatments Tested in This Trial?

Interventions

• tPBM

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.

How Is the Trial Designed?

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).

tPBM is already approved in United States for the following indications:

Approved in United States as Cognilum for:

• Moderate to severe autism spectrum disorder (ASD) in pediatric patients aged 2 to 6 years

Who Is Running the Clinical Trial?

Richard Frye

Lead Sponsor

Trials

2

Recruited

1,000+

Published Research Related to This Trial

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) 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]

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) 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]

Transcranial photobiomodulation (tPBM) using a 1,064-nm laser significantly increases levels of oxygenated hemoglobin and oxidized cytochrome c oxidase in the brain, confirming previous findings over a 3-year study with 20 participants.

The study demonstrated that tPBM is effective in both young (average age 26.7) and older adults (average age 68.2), showing similar increases in brain metabolism and blood flow, indicating its potential as a safe and effective intervention across different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Photobiomodulation (tPBM) With 1,064-nm Laser to Improve Cerebral Metabolism of the Human Brain In Vivo. Pruitt, T., Wang, X., Wu, A., 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]

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) 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11814471/

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05363982

Evaluation of Transcranial Photobiomodulation in Autism ... A preliminary open study in 10 depressed subjects has shown that the tPBM was safe, effective and well tolerated. More recently, efficacy and safety of tPBM was ...

3. 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.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT04569058

NCT04569058 | Transcranial Photobiomodulation Therapy ... Study Overview. Brief Summary. An open label trial to assess the safety and efficacy of transcranial photobiomodulation (tPBM) in improving autistic traits ...

6. 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 ...

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

Transcranial Photobiomodulation for the Treatment of ... It is important to mention that the database contains only the data of patients who accepted treatment among all the ones to which was proposed.