Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder
State University of New York - Upstate Medical University
Summary
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.
Description
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 clinic…
Eligibility
- Age range
- 2–8 years
- Sex
- All
- Healthy volunteers
- No
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).
Interventions
- DeviceCognilum TM: Light Treatment Condition
The children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks.
Locations (2)
- Mt. Sinai Medical CenterNew York, New York
- Golisano Center for Special NeedsSyracuse, New York