Using light therapy to reduce symptoms of autism in children
Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder
This study is testing if a light therapy device can help reduce autism symptoms in children aged 2 to 8.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 2 Years to 8 Years |
| Sex | All |
| Sponsor | State University of New York - Upstate Medical University Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06006637 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New York, New York and 1 other locations
- Mt. Sinai Medical Center — New York, New York, United States (Recruiting)
- Golisano Center for Special Needs — Syracuse, New York, United States (Recruiting)
Study contacts
- Study coordinator: William E Sullivan, PhD
- Email: sullivaw@upstate.edu
- Phone: 315-464-3932
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.