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.

NCT06006637

Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

Recruiting
NAAges 2–8InterventionalTreatment
State University of New York - Upstate Medical University
~80 participants
Updated 2025-10-14 on ClinicalTrials.gov
What's tested:Cognilum TM: Light Treatment Condition

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Childhood Autism Rating Scale, Second edition
Measured over 10 weeks
Autism Spectrum Disorder

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.

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Eligibility criteria

Inclusion

Ages 2 - 8
Autism spectrum disorder diagnosis
CARS-2 score of 30 - 45

Exclusion

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).
  • 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.