Light Therapy for Autism

(TPBMASD Trial)

Recruiting in New York (>99 mi)

+1 other 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

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a special headband that shines infrared light on the heads of children aged 2 to 6 with moderate to severe autism. The light may help improve brain function and reduce autism symptoms.

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 data supports the effectiveness of the treatment Cognilum TM for autism?

Research on photobiomodulation, a therapy using red to near-infrared light, shows it may help improve brain function and reduce symptoms in autism, such as social difficulties and repetitive behaviors. A study found that 50% of adults with autism who received this light therapy showed significant improvement in social responsiveness and overall functioning. ^{1 2 3 4 5}

Is light therapy, also known as Cognilum TM, safe for humans?

There is no specific safety data available for light therapy or Cognilum TM in the provided research articles. ^{6 7 8 9 10}

How does the treatment Cognilum TM differ from other treatments for autism?

Cognilum TM, involving light therapy, is unique because it uses transcranial photobiomodulation (tPBM), which involves applying red to near-infrared light to the brain to improve brain function and reduce autism symptoms. Unlike traditional treatments, it is non-pharmacological and focuses on enhancing brain connectivity and reducing inflammation, offering a novel approach for managing autism. ^{1 2 3 11 12}

Research Team

Yuli Fradkin, MD

Principal Investigator

RDT Group NJ

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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 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]

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]

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) 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]

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]

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

Transcranial Photobiomodulation in Adults with High-Functioning Autism Spectrum Disorder: Positive Findings from a Proof-of-Concept Study. [2022]

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

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

4. United States 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. [2023]

5. China pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of electro-acupuncture as a treatment for childhood autism using single photon emission computed tomography. [2021]

6. France pubmed.ncbi.nlm.nih.gov

[Review of psychopharmacological treatments in adolescents and adults with autistic disorders]. [2007]

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

Safety and Efficacy of Memantine in Children with Autism: Randomized, Placebo-Controlled Study and Open-Label Extension. [2022]

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

A pilot study of clomipramine in young autistic children. [2022]

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

Effect of Adding l -Carnitine to Risperidone on Behavioral, Cognitive, Social, and Physical Symptoms in Children and Adolescents With Autism: A Randomized Double-Blinded Placebo-Controlled Clinical Trial. [2023]

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

Autism: biomedical complementary treatment approaches. [2013]

11. Switzerland pubmed.ncbi.nlm.nih.gov

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

12. Switzerland pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). [2022]