What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) include behavioral therapies, medications, and neuromodulation techniques. For treatments similar to Transcranial Photobiomodulation (tPBM), such as Transcranial Magnetic Stimulation (TMS) and light therapy, side effects are generally mild but can include headaches, lightheadedness, tingling, and in rare cases, more severe neurological effects. Light therapy may also cause eye strain or sleep disturbances if not properly managed. Overall, these treatments are considered relatively safe with proper medical supervision.

What prior FDA approvals exist?

The FDA has approved two medications for the treatment of irritability associated with Autism Spectrum Disorder (ASD): risperidone and aripiprazole. These medications are antipsychotics and do not involve light or neuromodulation techniques. Currently, there are no FDA-approved treatments specifically using Transcranial Photobiomodulation (tPBM) or similar light-based neuromodulation for Autism. Research in this area is ongoing, as evidenced by clinical trials exploring the efficacy of tPBM in managing symptoms of Autism.

What other types of research exist?

Promising novel alternatives to Transcranial Photobiomodulation (tPBM) for autism patients include: 1) Repetitive Transcranial Magnetic Stimulation (rTMS), which has shown potential in various studies for improving neurocognitive functions. 2) Transcranial Direct-Current Stimulation (tDCS), which has been explored for its effects on neurocognition in bipolar patients and may have applications in autism. 3) Vagus Nerve Stimulation (VNS), which has demonstrated efficacy in treatment-resistant depression and could be considered for autism. These alternatives have been studied for their neuromodulatory effects and may offer benefits for autism treatment.

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Procedure

Light Therapy for Autism (IPMR ASD Trial)

N/A

Recruiting

Research Sponsored by State University of New York - Upstate Medical University

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 10 weeks

Summary

This trial will test if shining a special light on the brain using a headband can help improve symptoms in autistic children by boosting brain activity.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects are not listed in the provided information. Generally, tPBM is considered non-invasive but may include discomfort or other reactions at the site of application.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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

Childhood Autism Rating Scale, Second edition

Secondary study objectives

Clinical Global Impressions Scale

Social Responsiveness Scale, Second Edition

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CognilumTMExperimental Treatment1 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 controlPlacebo Group1 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.

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

Transcranial Photobiomodulation (tPBM) is a treatment that uses light to stimulate cellular activity in the brain. This therapy involves the application of near-infrared light to the scalp, which penetrates the skull and reaches brain tissues. The light energy is absorbed by cellular mitochondria, leading to increased production of adenosine triphosphate (ATP), enhanced cellular metabolism, and reduced oxidative stress. These effects can improve neuronal function and connectivity, which are often impaired in Autism Spectrum Disorder (ASD). This matters for Autism patients as it offers a non-invasive method to potentially enhance brain function and alleviate some of the behavioral and cognitive symptoms associated with ASD.

Optogenetic Dissection of Neural Circuits Underlying Stress-Induced Mood Disorders.The Treatment of Sleep Dysfunction in Neurodegenerative Disorders.Social behavior in mice following chronic optogenetic stimulation of hippocampal engrams.

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Who is running the clinical trial?

State University of New York - Upstate Medical UniversityLead Sponsor

174 Previous Clinical Trials

27,461 Total Patients Enrolled

5 Trials studying Autism Spectrum Disorder

7,714 Patients Enrolled for Autism Spectrum Disorder

JelikaLite LLCIndustry Sponsor

2 Previous Clinical Trials

59 Total Patients Enrolled

2 Trials studying Autism Spectrum Disorder

59 Patients Enrolled for Autism Spectrum Disorder

~20 spots leftby Oct 2025

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