Cognilum™ Light Treatment for Autism Spectrum Disorder
This study is testing a device called Cognilum™ that uses light therapy (transcranial photobiomodulation or tPBM) to help reduce symptoms of Autism Spectrum Disorder. The Cognilum™ device delivers near infra-red (NIR) light to specific brain areas. Researchers want to see if this light treatment can improve scores on scales that measure autism symptoms, like the Childhood Autism Rating Scale (CARS-2). You might be able to join if you are an autistic child between 2 and 8 years old with a CARS-2 score between 30 and 45. The study is looking for 80 participants and its current status is unclear.
- Study design
- This is a randomized, double-blind, sham-controlled study involving 80 autistic children. This means some children will receive the active light treatment, and others will receive a sham (inactive) treatment, without anyone knowing which they are getting.
- What's involved
- Children will wear the Cognilum™ device for about 10 minutes at a time, twice a week, for 10 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 10 weeks, which is when the treatment period ends.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder
At a glance
Conditions
NCT06006637
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Golisano Center for Special Needs
Syracuse, New Yorkstudy coordinator listed
Recruiting
Mt. Sinai Medical Center
New York, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
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Inclusion
Exclusion
What this trial measures
- Childhood Autism Rating Scale, Second edition10 weeks
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.