Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

Study Overview
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Brief Summary
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This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University with 40 autistic children evaluating the effects of transcranial photobiomodulation (tPBM) on multiple clinically validated scales.

Detailed Description
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The proposed intervention will noninvasively deliver near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The Cognilum system is a non-invasive headband medical device specifically designed to safely and comfortably deliver tPBM to autistic children. Cognilum has been designated as a non-significant risk breakthrough device by the Food and Drug Administration. This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University with 40 autistic children using Cognilium device and measuring the impact using multiple clinically validated scales. Hypothesis 1: Significant reduction of average Childhood Autism Rating Scores (CARS; before and after treatment comparison) in the active group compared to sham-control group. Hypothesis 2: Significant change in average scores (before and after treatment comparison) on the Social Responsiveness Scale (SRS), and Clinical Global Impression - Improvement (CGI-I) scale in the active group compared to sham control group.

Official Title
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Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

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: Ages 2 - 8 Autism spectrum disorder diagnosis CARS-2 score of 30 - 45 Exclusion Criteria: CARS scores less than 30 or over 45. Taking psychotropic medications. Having skin lesions on scalp Having history of seizures Having history of abnormal EEG Being a relative of the PI or a researcher Having implanted devices (including cochlear implants).

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 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, Sham-controlled, Double Blind, Mixed-Design study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CognilumTM<br>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. | Device: Cognilum TM: Light Treatment Condition<br>* The children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks.<br>|
| Sham Comparator: Sham control<br>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. | Device: Cognilum TM: Light Treatment Condition<br>* The children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Childhood Autism Rating Scale, Second edition | Psychometrically sound measure for identifying children with autism and their symptom severity through quantifiable ratings based on direct observation. Raw scores may range from 15 to 60, which are then converted to T-scores. Higher scores indicate greater severity. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Responsiveness Scale, Second Edition | Psychometrically sound measure for identifying the presence and severity of social impairment within the autism spectrum and differentiates it from that which occurs in other disorders. Raw scores may range from 65 to 260, which are then converted to T-scores. Higher scores indicate greater severity. | 10 weeks | 
| Clinical Global Impressions Scale | A well-established, brief assessment of the clinician's view of the patient's global functioning prior to and after initiating intervention. Ratings range from 1 (Normal) to 7 (Among the most severe). | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transcranial photobiomodulation, Autism Spectrum Disorder