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.
Ages 2 - 8
Autism spectrum disorder diagnosis
CARS-2 score of 30 - 45
CARS scores less than 30 or over 45.
Taking psychotropic medications.
Having skin lesions on scalp
Having history of seizures
Parallel
Cognilum TM: Light Treatment Condition
DeviceThe children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks.
Childhood Autism Rating Scale, Second edition
Psychometrically sound measure for identifying children with autism and their symptom severity through quantifiable ratings based on direct observation. Raw scores may range from 15 to 60, which are then converted to T-scores. Higher scores indicate greater severity.
Social Responsiveness Scale, Second Edition
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 disorders. Raw scores may range from 65 to 260, which are then converted to T-scores. Higher scores indicate greater severity.
Clinical Global Impressions Scale
A well-established, brief assessment of the clinician's view of the patient's global functioning prior to and after initiating intervention. Ratings range from 1 (Normal) to 7 (Among the most severe).
Clinical Interviews
Caregiver interviews obtaining information on the participant's functioning.
Aberrant Behavior Checklist
Behavior assessment
Repetitive Behavior Scale
Assessment of restricted and repetetive behaviors
Sensory Profile Caregiver Questionnaire -- Second Edition
Assessment of sensory needs
Click on the lead sponsor to view all of their trials.
State University of New York - Upstate Medical University
Lead sponsor
JelikaLite LLC
Collaborator
Mt. Sinai School of Medicine, New York, New York
Collaborator
MetroEHS
Collaborator
