Recruiting

Observational Study

Sponsor:

State University of New York - Upstate Medical University

Code:

NCT06006637

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 2 - 8

Healthy Volunteers: Not accepted

Interventions

Cognilum TM: Light Treatment Condition

Study Details

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

Conditions

Autism Spectrum Disorder

Study ID

NCT06006637

Start date

Oct 17, 2023

Status verified date

Dec, 2024

Completion date

Aug 15, 2026

Anticipated

Primary completion date

Aug 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 8

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Childhood Autism Rating Scale, Second edition [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

William E Sullivan, PhD

315-464-3932sullivaw@upstate.edu

Henry S Roane, PhD

315-464-3555roaneh@upstate.edu

Locations

Mt. Sinai Medical Center

Recruiting

New York, New York, United States, 10029

Contacts

Alexander Kolevzon, MD

212-659-8752alexander.kolevzon@mssm.edu

Catherine Sancimino, PhD

catherine.sancimino@mssm.edu

Golisano Center for Special Needs

Recruiting

Syracuse, New York, United States, 13210

Contacts

Henry S Roane, PhD

315-464-3555roaneh@upstate.edu

More Information

Sponsor

State University of New York - Upstate Medical University

Last update posted

Oct 14, 2025

Last verified

Dec, 2024

Keywords

  • Transcranial photobiomodulation
  • Autism Spectrum Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by State University of New York - Upstate Medical University on 2025-10-14.