Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai Medical Center with 80 autistic children evaluating the effects of transcranial photobiomodulation (tPBM) on multiple clinically validated scales.

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 and Mt. Sinai with 80 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.

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).