Light Therapy for Autism

(TPBMASD Trial)

No longer recruiting at 1 trial location

Overseen By Eugenia Steingold, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: JelikaLite LLC

Must not be taking: Psychotropic, Light-activated drugs

Disqualifiers: Severe self-injury, Epilepsy, Unstable condition, others

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether light therapy, specifically photobiomodulation using a device called Cognilum, can reduce symptoms of moderate to severe autism in young children. The researchers compare real light therapy to a placebo (a non-active treatment) to determine if significant improvement occurs. Children diagnosed with moderate to severe autism, who are not experiencing severe behavioral issues, might be suitable for this study. Participants will wear a device on their heads twice a week for eight weeks, with results assessed through parental interviews and other evaluations. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research in autism treatment.

Will I have to stop taking my current medications?

Yes, participants must stop taking any psychotropic medications (drugs that affect mood, perception, or behavior) before joining the trial.

What prior data suggests that this photobiomodulation device is safe for children with autism?

Research shows that the treatment used in this trial, transcranial photobiomodulation (tPBM) with the Cognilum TM device, is generally well-tolerated by young children. Studies involving children aged 2 to 6 years suggest that tPBM might be a safe option for treating autism spectrum disorder (ASD). These studies have not reported any serious side effects, indicating good safety.

The Cognilum TM device uses light to stimulate certain areas of the brain. Although this might sound complicated, the process is non-invasive, meaning it doesn't involve surgery or inserting anything into the body. Research on similar treatments suggests safety, but more studies are needed to confirm these findings in larger groups of children. It is important to consult a healthcare provider to understand the potential risks and benefits before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CognilumTM because it offers a unique approach to treating autism through photobiomodulation. Unlike traditional therapies such as behavioral interventions and medications, CognilumTM uses near-infrared light (830nm) to stimulate specific areas of the brain. This method is non-invasive and targets brain activity directly, which could lead to improvements in symptoms without the side effects associated with medications. This innovative approach has the potential to provide a new avenue for managing autism symptoms more effectively.

What evidence suggests that Cognilum TM might be an effective treatment for autism?

This trial will compare the effects of the CognilumTM device, which uses transcranial photobiomodulation (tPBM) to stimulate certain brain areas with near-infrared light, to a placebo condition where the device remains inactive. Studies have shown that tPBM might help with autism by reducing symptoms like difficulty with communication and daily activities. Specifically, early research indicated that children who received this treatment showed improvements in focus, eye contact, speech, and behavior. These initial results are promising, but more research is needed to confirm the benefits for larger groups. Overall, tPBM appears to be a safe option for children with autism, potentially improving their quality of life. ^{2 4 5 6 7}

Who Is on the Research Team?

Yuli Fradkin, MD

Principal Investigator

RDT Group NJ

Are You a Good Fit for This Trial?

This trial is for children aged 2-6 with moderate to severe autism. They can participate even if they have another psychiatric disorder, as long as it's not excluded, and are allowed to continue behavioral therapies during the study. Parents must understand the study and consent.

Inclusion Criteria

Parents of participants must be aware of the nature of the study.

Participants between the ages of 2 and 6 years old, both male and female, of any race.

It's okay if you're receiving behavioral therapy while participating in the study. The analysis will take into account the participants receiving therapy in both the control and experimental groups. The study found no problems or conflicts between the therapy and the treatment being studied.

Exclusion Criteria

Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudine (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid (ALA)- for non-melanoma skin cancer)

You are currently taking medication for mental health reasons.

The child has been engaging in severe self-harming behavior or severe aggressive behavior towards themselves or others in the past week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Transcranial photobiomodulation is administered twice a week for 8 weeks

8 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognilum TM

Trial Overview The trial tests whether transcranial photobiomodulation (light therapy) can reduce autism symptoms in children. It involves light treatment twice a week for 8 weeks, with results measured by interviews, CARS scores, and EEG data.

How Is the Trial Designed?

Group I: CognilumTM Experimental Treatment 1 Intervention

During the study participants will be wearing the photobiomodulation device Cognilum. The device will administer the stimulation of near infrared light (830nm) to specific areas of the child's brain.

Group II: Placebo condition Placebo Group 1 Intervention

During the study participants will be wearing the photobiomodulation device. The device will not be turned on and therefore no brain stimulation with near infrared light (830nm) will be provided.

Who Is Running the Clinical Trial?

JelikaLite LLC

Lead Sponsor

Trials

3

Recruited

100+

Published Research Related to This Trial

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 magnetic stimulation (TMS) shows promise as a safe treatment for cognitive and behavioral symptoms in intellectually capable individuals with autism spectrum disorder (IC-ASD), with a meta-analysis of 12 studies indicating significant improvements in cognitive outcomes and specific symptoms.

The study highlights the need for improved research methodologies, such as using neuronavigation and targeting different brain regions, to enhance the efficacy of TMS treatments in future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Response of Transcranial Magnetic Stimulation in Intellectually Capable Youth and Young Adults with Autism Spectrum Disorder: A Systematic Review and Meta-Analysis. Smith, JR., DiSalvo, M., Green, A., et al.[2023]

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]

In a 12-week randomized, placebo-controlled trial involving 121 children with autism, memantine did not show significant clinical efficacy in improving symptoms, although it was well-tolerated with only mild to moderate adverse effects reported.

The study found that while memantine was safe and tolerable, it did not lead to improvements in the primary outcome measure of social responsiveness, and one communication measure even worsened in the memantine group compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Memantine in Children with Autism: Randomized, Placebo-Controlled Study and Open-Label Extension. Aman, MG., Findling, RL., Hardan, AY., 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]

Light therapy is an effective, evidence-based treatment for Seasonal Affective Disorder, influencing circadian rhythms that affect sleep, mood, and cognition, based on 40 years of clinical trials.

For optimal results, light therapy should use devices that provide 10,000 lux of white light for 30-60 minutes in the early morning, with ongoing monitoring to adjust treatment as needed and manage any side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). Wirz-Justice, A., Terman, AM.[2022]

A review of studies on pharmacological treatments for autism in adolescents and adults found that while some medications, like haloperidol and risperidone, show effectiveness in managing symptoms, there is a lack of controlled studies validating their safety and efficacy.

The review highlights that autism may involve dysfunctions in neuromediation systems, particularly with serotonin and dopamine, suggesting that future research should focus on these systems to develop more effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Review of psychopharmacological treatments in adolescents and adults with autistic disorders]. Baghdadli, A., Gonnier, V., Aussilloux, C.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11086174/

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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06006637

Study Details | NCT06006637 | Integrated Platform for ... This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai with 80 autistic children ...

3. horizonscan.ecri.org horizonscan.ecri.org/report/topics/801

Transcranial photobiomodulation system (Cognilum System ... The Cognilum System is intended to alleviate autism symptoms, thus helping improve communication and daily living skills so that children with ASD can enjoy ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06352372/safety-and-efficacy-of-tpbm-for-epileptiform-activity-in-autism

Safety and Efficacy of tPBM for Epileptiform Activity in Autism The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may ...

5. jelikalite.com jelikalite.com/

JelikaLite - Precision Autism Through Light That is why we are developing Cognilum, an innovative solution to enhance the child's communication skills while reducing a child's troublesome autism symptoms, ...

6. 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.

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1221193/epub

Transcranial photobiomodulation in children aged 2–6 years Transcranial photobiomodulation in children aged 2–6 years: a randomized sham-controlled clinical trial assessing safety, efficacy, and impact ...