Transcranial Photobiomodulation for Reducing Autism Symptoms in Children

Study Overview
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Brief Summary
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The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 6, who have been diagnosed with moderate to severe autism. Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 8 weeks. Results will be measured through parental interviews, standardized CARS (Childhood Autism Rating Scales) and data collected from EEG.

Detailed Description
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The CognilumTM System is a non-invasive device that uses infrared light (IR), delivered through light emitting diodes (LEDs) built into a head band worn by the patient during treatment. The proposed clinical investigation is determined by the FDA to be a nonsignificant risk (NSR) device study.

Official Title
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Transcranial Photobiomodulation for Reducing Autism Symptoms in Children

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Device: Cognilum TM: Light Treatment Condition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participants between 2 years and 6 years of age (inclusive), of all races. Previously diagnosed with moderate or severe ASD by a licensed professional. Participants may be receiving any behavioral intervention therapy (e.g., ABA, Floor Time) during the course of the treatment. The final statistical analysis will control for the participants receiving behavioral therapies in control and experimental conditions. We expect the majority of the participants in both control and experimental conditions to be receiving behavioral therapies. There is no known interactions or complications of tPBM with behavioral therapy. Parents of participants must understand the nature of the study. Parents of participants must sign an IRB- approved informed consent form before initiation of any study procedures. Parents of participants must have a level of understanding sufficient to communicate with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. Participant child experiencing a major psychiatric disorder will be allowed to participate in the study provided they do not meet any exclusionary criteria. The participant child is willing to participate in this study. Exclusion Criteria: Participant child is experiencing severe self-injurious behavior or severe aggressive behavior to self or others (within past 7 days). Participant has been diagnosed with another psychiatric or neurological disorder (e.g. epilepsy) or have exhibited symptoms of major psychiatric disorders within the last 30 days. Participant has an unstable medical condition (that requires clinical attention). Participant has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo). Participant has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve). Participant has receiving medication on a regular basis for Autism or any other medical condition. 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). Current treatment with a psychotropic medication. Investigator and his/her immediate family, defined as the investigator's child or grandchild. -

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a Randomized, Placebo-controlled, Double Blind, Mixed Design study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CognilumTM<br>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. | Device: Cognilum TM: Light Treatment Condition<br>* The children will wear the CognilumTM device for approximately 15 minutes at a time, twice a week, for a period of 8 weeks.<br>|
| Placebo Comparator: Placebo condition<br>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. | Device: Cognilum TM: Light Treatment Condition<br>* The children will wear the CognilumTM device for approximately 15 minutes at a time, twice a week, for a period of 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Autism symptoms | Significant change of total score on a Childhood Autism Rating Scales in the experimental condition but not in the control condition (measured by ANOVA) | 8 weeks | 
| EEG - 1 | Absolute power spectrum alterations will be measured in all oscillatory frequency bands (e.g. Alpha, Beta, Gamma, Delta, Theta, etc.) . | 8 weeks | 
| EEG - 2 | The power spectrum across all electrodes for each oscillatory frequency band will be averaged, and the ratio of post- over pre-session rest-EEG for both active and sham conditions will be compared. | 8 weeks |