Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder (IPMR ASD)

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.

All participants and their caregivers will be held blind to group assignment. The PI will also remain blind to participant group assignment and conduct the pre- and post-assessment batteries (i.e., CARS-2, SRS, and CGI-I). Two clinical research assistants and co-investigator, will randomly assign participants to groups and have knowledge of their assignment. A third research assistant will also be held blind to group assignment and complete weekly interviews with caregivers.

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.

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.

The children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks.

Psychometrically sound measure for identifying children with autism and their symptom severity through quantifiable ratings based on direct observation.

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 disorder.

A well-established, brief assessment of the clinician's view of the patient's global functioning prior to and after initiating intervention.

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 medications on a regular basis 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).