What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) that are similar to transcranial photobiomodulation include repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS). Known side effects of these neuromodulation techniques are generally mild and may include headaches, scalp discomfort, tingling, lightheadedness, and, in rare cases, seizures. Long-term safety data is limited, so larger trials are needed to fully understand the risks.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for Autism Spectrum Disorder that are similar to transcranial photobiomodulation, which uses light stimulation to influence brain function. The FDA has approved medications like risperidone and aripiprazole to treat irritability associated with ASD, but these are antipsychotic drugs and do not involve neuromodulation techniques. Research into novel treatments such as transcranial photobiomodulation is ongoing, but these methods have not yet received FDA approval for ASD.

What other types of research exist?

Promising novel alternatives to Transcranial Photobiomodulation for Autism Spectrum Disorder patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in various neuropsychiatric conditions and is being explored for ASD. 2) Transcutaneous Supraorbital Nerve Stimulation, which has demonstrated pain reduction in migraine and could potentially be adapted for ASD. 3) Vagus Nerve Stimulation (VNS), which has shown benefits in treatment-resistant depression and is being investigated for other neurological conditions.

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Light Therapy

Light Therapy for Autism (TPBMASD Trial)

N/A

Waitlist Available

Led By Yuli Fradkin, MD

Research Sponsored by JelikaLite LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of transcranial photobiomodulation are not detailed in this summary but may include discomfort at the site of application or changes in mood or behavior; however, these should be monitored closely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Autism Symptoms

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CognilumTMExperimental Treatment1 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 conditionPlacebo Group1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognilum TM: Light Treatment Condition

2022

N/A

~60

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism Spectrum Disorder (ASD) include behavioral and educational interventions, which work by reinforcing desired behaviors and developing essential skills through structured, individualized programs. Emerging treatments like transcranial photobiomodulation involve using light to stimulate brain function, potentially influencing neural activity and reducing ASD symptoms. These mechanisms are important as they help tailor interventions to individual needs, thereby maximizing therapeutic outcomes for ASD patients.