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 CARS2 (Childhood Autism Rating Scales, 2nd Edition) and data collected from EEG.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
34
The children will wear the CognilumTM device for up to 15 minutes at a time, twice a week, for a period of 8 weeks.
Dr. Steingold Psychology PC
Brooklyn, New York, United States
Dr. Steingold Psychology PC
New York, New York, United States
Change in Autism Symptoms
Childhood Autism Rating Scales, Second Edition (CARS, 2nd Edition), patients were evaluated after conclusion of the study. CARS is a validated clinical rating scale that can be used by a trained clinician to rate items indicative of ASD after direct observation of the child. The scale consists of fifteen items that correspond to the different core domains (e.g., verbal communication, emotional response, and relationships with people) that can be affected by ASD. Total score (sum of all 15 sub-scales) can range from a low of 15 (no ASD) to a high of 60 (severe ASD). For the outcome measure we took the difference between the CARS score at the completion of the study and the CARS score at baseline.
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.