NCT06006637

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Oct 2023Aug 2026

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 17, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

October 14, 2025

Status Verified

December 1, 2024

Enrollment Period

2.8 years

First QC Date

August 17, 2023

Last Update Submit

October 10, 2025

Conditions

Autism Spectrum Disorder

Keywords

Transcranial photobiomodulationAutism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Social Responsiveness Scale, Second Edition

    10 weeks

  • Clinical Global Impressions Scale

    10 weeks

Other Outcomes (4)

  • Clinical Interviews

    10 weeks

  • Aberrant Behavior Checklist

    10 weeks

  • Repetitive Behavior Scale

    10 weeks

  • +1 more other outcomes

Study Arms (2)

CognilumTM

EXPERIMENTAL

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

Sham control

SHAM COMPARATOR

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

Interventions

Cognilum TM: Light Treatment ConditionDEVICE

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

CognilumTMSham control

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mt. Sinai Medical Center

New York, New York, 10029, United States

RECRUITING

Golisano Center for Special Needs

Syracuse, New York, 13210, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

William E Sullivan, PhD

CONTACT

315-464-3932sullivaw@upstate.edu

Henry S Roane, PhD

CONTACT

315-464-3555roaneh@upstate.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All participants and their caregivers will be held blind to group assignment. The PI will also remain blind to participant group assignment and conduct the pre- and post-assessment batteries (i.e., CARS-2, SRS, and CGI-I). Two clinical research assistants and co-investigator, will randomly assign participants to groups and have knowledge of their assignment. A third research assistant will also be held blind to group assignment and complete weekly interviews with caregivers.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a Randomized, Sham-controlled, Double Blind, Mixed-Design study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

October 17, 2023

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

October 14, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

No individual participant data (IPD) will be available to other researchers

Locations

US(2)