Clinical trial Recruiting at 2 sites Interventional Ages 2 to 8

Using light therapy to reduce symptoms of autism in children

Official title: Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

Run by State University of New York - Upstate Medical University · NCT06006637 · Data updated 2026-11-12

This study is testing if a light therapy device can help reduce autism symptoms in children aged 2 to 8.

More Autism Spectrum Disorder trials

Quick facts

Study typeInterventional
Ages2 Years to 8 Years
SexAll
Enrollment80 (estimated)
SponsorState University of New York - Upstate Medical University
Academic / other
Locations2 sites (New York, New York and 1 other locations)
StatusRecruiting
StartedOctober 17, 2023
Main results expectedAugust 15, 2026
Study endsAugust 15, 2026
Registry record updatedOctober 14, 2025
Trial IDNCT06006637 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 2 to 8 diagnosed with autism spectrum disorder and scoring between 30 and 45 on the Childhood Autism Rating Scale.

Probably not a fit

Patients with CARS scores below 30 or above 45, those taking psychotropic medications, or those with certain medical histories may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effects of transcranial photobiomodulation (tPBM) on autistic children aged 2 to 8. The intervention involves using a non-invasive device called Cognilum, which delivers near infra-red light to specific brain areas. The study is randomized, double-blind, and sham-controlled, involving 40 participants and measuring outcomes using validated scales such as the Childhood Autism Rating Scale (CARS) and the Social Responsiveness Scale (SRS). The goal is to assess whether tPBM can significantly reduce autism symptoms compared to a sham treatment.

Why it matters

Potential benefit: If successful, this approach could provide a novel non-invasive treatment option for reducing symptoms of autism in young children.

How similar studies have gone: While the use of tPBM is a novel approach in this context, similar studies have shown promise in other neurological conditions, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
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).

Where it's running

  • Mt. Sinai Medical Center
    New York, New York, United States
    Recruiting
  • Golisano Center for Special Needs
    Syracuse, New York, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.