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.
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.