An interventional study of Cognilum TM: Light Treatment Condition in Autism Spectrum Disorder, sponsored by State University of New York - Upstate Medical University. Recruiting at 2 sites in United States. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by State University of New York - Upstate Medical University · Not applicable, Interventional, and Treatment
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.
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 and Mt. Sinai with 80 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.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 80 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →State University of New York - Upstate Medical University is the lead sponsor of 157 studies on the registry; 18 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Cognilum TM: Light Treatment Condition
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.
Device: Cognilum 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.
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.
Time frame: 10 weeks
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.
Time frame: 10 weeks
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).
Time frame: 10 weeks
Clinical Interviews
Caregiver interviews obtaining information on the participant's functioning.
Time frame: 10 weeks
Aberrant Behavior Checklist
Behavior assessment
Time frame: 10 weeks
Repetitive Behavior Scale
Assessment of restricted and repetetive behaviors
Time frame: 10 weeks
Sensory Profile Caregiver Questionnaire -- Second Edition
Assessment of sensory needs
Time frame: 10 weeks
Plan to share: No — No individual participant data (IPD) will be available to other researchers
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Aug 2026, 33 months after the start.
Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 33 months is above that.
Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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State University of New York - Upstate Medical University →