Status:
RECRUITING
Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder
Lead Sponsor:
State University of New York - Upstate Medical University
Collaborating Sponsors:
JelikaLite LLC
Mt. Sinai School of Medicine, New York, New York
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
2-8 years
Phase:
NA
Brief Summary
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 o...
Detailed Description
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 br...
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).
Key Trial Info
Start Date :
October 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06006637
Start Date
October 17 2023
End Date
August 15 2026
Last Update
October 14 2025
Active Locations (2)
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1
Mt. Sinai Medical Center
New York, New York, United States, 10029
2
Golisano Center for Special Needs
Syracuse, New York, United States, 13210