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NCT Number: NCT06006637

Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mt. Sinai Medical Center, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Cognilum TM: Light Treatment Condition

Device

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

Primary outcomes

  1. Childhood Autism Rating Scale, Second edition

    Time frame: 10 weeks

    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.

Secondary outcomes

  1. Social Responsiveness Scale, Second Edition

    Time frame: 10 weeks

    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.

  2. Clinical Global Impressions Scale

    Time frame: 10 weeks

    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).

Other outcomes

  1. Clinical Interviews

    Time frame: 10 weeks

    Caregiver interviews obtaining information on the participant's functioning.

  2. Aberrant Behavior Checklist

    Time frame: 10 weeks

    Behavior assessment

  3. Repetitive Behavior Scale

    Time frame: 10 weeks

    Assessment of restricted and repetetive behaviors

  4. Sensory Profile Caregiver Questionnaire -- Second Edition

    Time frame: 10 weeks

    Assessment of sensory needs

Study contacts

Contact information is provided by the study sponsor or research team.

Henry S Roane, PhD

CONTACT

[email protected]

315-464-3555

William E Sullivan, PhD

CONTACT

[email protected]

315-464-3932

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Collaborators

  • JelikaLite LLC
  • MetroEHS
  • Mt. Sinai School of Medicine, New York, New York

Registry information

Acronym: IPMR ASD

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 23, 2023
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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