RecruitingNot ApplicableNCT06006637

Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder


Sponsor

State University of New York - Upstate Medical University

Enrollment

80 participants

Start Date

Oct 17, 2023

Study Type

INTERVENTIONAL

Conditions

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 of transcranial photobiomodulation (tPBM) on multiple clinically validated scales.


Eligibility

Min Age: 2 YearsMax Age: 8 Years

Inclusion Criteria3

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

Exclusion Criteria7

  • 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).

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Interventions

DEVICECognilum TM: Light Treatment Condition

The children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks.


Locations(2)

Mt. Sinai Medical Center

New York, New York, United States

Golisano Center for Special Needs

Syracuse, New York, United States

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NCT06006637


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