Light Therapy for Autism

(IPMR ASD Trial)

Recruiting at 1 trial location

Overseen By Henry S Roane, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York - Upstate Medical University

Must not be taking: Psychotropic medications

Disqualifiers: Seizures, Abnormal EEG, Implanted devices, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how light therapy affects children with autism. Researchers are testing a device called Cognilum, which uses near-infrared light to stimulate brain areas that might improve autism symptoms. Participants will receive either this light therapy or a sham treatment, which appears identical but does not deliver the light. Children aged 2 to 8 with an autism diagnosis and specific symptom levels may qualify for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new autism therapies.

Do I need to stop my current medications to join the trial?

Yes, you cannot participate in the trial if you are taking psychotropic medications (drugs that affect mood, perception, or behavior).

What prior data suggests that this device is safe for autistic children?

Research shows that transcranial photobiomodulation (tPBM) might be safe and helpful for children with autism spectrum disorder (ASD). One study with children aged 2 to 6 years found tPBM to be safe and well-tolerated, suggesting it could be a viable option for young children with autism. Another study with adults who have depression also found tPBM to be safe and effective, supporting its overall safety. These findings provide a positive outlook on using tPBM to treat autism in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for autism, which often include behavioral therapies and medications like antipsychotics, CognilumTM offers a unique approach by using light therapy. This treatment involves transcranial photobiomodulation, where near-infrared light targets specific brain areas. Researchers are excited about CognilumTM because it represents a non-invasive and potentially side-effect-free alternative, leveraging light to potentially influence brain function and improve symptoms. This innovative method could provide new hope for those seeking options beyond conventional therapy.

What evidence suggests that transcranial photobiomodulation is effective for autism?

Research has shown that transcranial photobiomodulation (tPBM) might be a promising treatment for autism. In one study, tPBM significantly reduced autism symptoms in 21 children over six months. Another study found it safe and effective, suggesting further exploration is warranted. This trial will evaluate the effectiveness of tPBM using the CognilumTM device, which administers near-infrared light to specific brain areas. Participants will either receive active stimulation with the CognilumTM device or be part of a sham control group where the device remains off. Overall, these early findings support the potential of tPBM as a non-drug and non-invasive option for managing autism symptoms. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for children aged 2-8 who have been diagnosed with Autism Spectrum Disorder and have a CARS-2 score between 30 and 45, indicating a certain level of autism symptoms. Details on who cannot participate are not provided.

Inclusion Criteria

Autism spectrum disorder diagnosis

I am between the ages of 2 and 8.

CARS-2 score of 30 - 45

Exclusion Criteria

I have skin lesions on my scalp.

CARS scores less than 30 or over 45

Being a relative of the PI or a researcher

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) using the Cognilum device or a sham device for 10 weeks

10 weeks

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 study tests the effects of transcranial photobiomodulation (tPBM), which uses light treatment called Cognilum TM, on autistic children. It's randomized and double-blind, meaning neither participants nor researchers know who gets real or sham treatment.

How Is the Trial Designed?

Group I: CognilumTM Experimental Treatment 1 Intervention

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

Group II: Sham control Placebo Group 1 Intervention

During the study participants will wear the transcranial 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?

State University of New York - Upstate Medical University

Lead Sponsor

Trials

176

Recruited

27,600+

JelikaLite LLC

Industry Sponsor

Trials

3

Recruited

100+

Mt. Sinai School of Medicine, New York, New York

Collaborator

Trials

1

Recruited

7+

MetroEHS

Collaborator

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/NCT05363982

Evaluation of Transcranial Photobiomodulation in Autism ... The main aim of this 8-week, prospective, placebo (sham) controlled study is to evaluate the efficacy, safety, and tolerability of tPBM with near-infrared light ...

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

Transcranial photobiomodulation system (Cognilum System ... Photobiomodulation is thought to increase mitochondrial energy production, which might enhance cell survival and reduce mediators of inflammation. Through use ...

4. withpower.com withpower.com/trial/phase-autistic-disorder-10-2020-3fa93

Light Therapy for Autism (TPBMASD Trial) Transcranial photobiomodulation (tPBM) over six months significantly reduced the severity of Autism Spectrum Disorder (ASD) symptoms in 21 children, as ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9680350/

Lights on for Autism: Exploring Photobiomodulation as an ... We highlight the idea that photobiomodulation can form an effective, safe, non-pharmacological and non-invasive treatment option for people with autism.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06006637

Integrated Platform for Measuring and Reducing Symptoms ... 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 ...

7. 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 ...

8. symplr.com symplr.com/publication/cognilum-transcranial-photobiomodulation-tpbm-for-autism-spectrum-disorder

Cognilum Transcranial Photobiomodulation (tPBM) for ... Cognilum is a wearable transcranial photobiomodulation (tPBM) device under investigation for the reduction of symptoms of moderate to severe autism spectrum ...

9. 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 ...