Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder (IPMR ASD)

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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: Cognilum TM: Light Treatment Condition

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 brain areas by Cognilum, a wearable device developed by Jelikalite. The Cognilum system is a non-invasive headband medical device specifically designed to safely and comfortably deliver tPBM to autistic children. Cognilum has been designated as a non-significant risk breakthrough device by the Food and Drug Administration. This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai with 80 autistic children using Cognilium device and measuring the impact using multiple clinically validated scales.

Hypothesis 1: Significant reduction of average Childhood Autism Rating Scores (CARS; before and after treatment comparison) in the active group compared to sham-control group.

Hypothesis 2: Significant change in average scores (before and after treatment comparison) on the Social Responsiveness Scale (SRS), and Clinical Global Impression - Improvement (CGI-I) scale in the active group compared to sham control group.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William E Sullivan, PhD; Phone Number: 315-464-3932; Email: sullivaw@upstate.edu
• Study Contact Backup: Name: Henry S Roane, PhD; Phone Number: 315-464-3555; Email: roaneh@upstate.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mt. Sinai Medical Center
      • Contact: Alexander Kolevzon, MD; Phone Number: 212-659-8752; Email: alexander.kolevzon@mssm.edu
      • Contact: Catherine Sancimino, PhD; Email: catherine.sancimino@mssm.edu
    • Syracuse, New York, United States, 13210
      • Recruiting
      • Golisano Center for Special Needs
      • Contact: Henry S Roane, PhD; Phone Number: 315-464-3555; Email: roaneh@upstate.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CognilumTM; During the study participants will be wear the transcranial photobiomodulation device Cognilum. The device will administer the stimulation of near infrared light (830nm) to specific areas of the child's brain.	Device: Cognilum 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.
Sham Comparator: Sham control; During the study participants will wear the transcranial photobiomodulation device. The device will not be turned on and therefore no brain stimulation with near infrared light (830nm) will be provided.	Device: Cognilum 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childhood Autism Rating Scale, Second edition	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.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Responsiveness Scale, Second Edition	Psychometrically sound measure for identifying the presence and severity of social impairment within the autism spectrum and differentiates it from that which occurs in other disorders. Raw scores may range from 65 to 260, which are then converted to T-scores. Higher scores indicate greater severity.	10 weeks
Clinical Global Impressions Scale	A well-established, brief assessment of the clinician's view of the patient's global functioning prior to and after initiating intervention. Ratings range from 1 (Normal) to 7 (Among the most severe).	10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Interviews	Caregiver interviews obtaining information on the participant's functioning.	10 weeks
Aberrant Behavior Checklist	Behavior assessment	10 weeks
Repetitive Behavior Scale	Assessment of restricted and repetetive behaviors	10 weeks
Sensory Profile Caregiver Questionnaire -- Second Edition	Assessment of sensory needs	10 weeks

Collaborators and Investigators

• Sponsor: State University of New York - Upstate Medical University
• Collaborators: Mt. Sinai School of Medicine, New York, New York; JelikaLite LLC; MetroEHS

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Autism Spectrum Disorder; Transcranial photobiomodulation
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 2041726; 111111 (Other Grant/Funding Number: FUZEhub)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data (IPD) will be available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No