Autism Spectrum Disorder Clinical Trial
Official title:
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 with 40 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 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. ;
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