Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

Part of paid clinical trials in New York, New York.

Sponsor
State University of New York - Upstate Medical University
Study ID
NCT06006637
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 8 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 17, 2023
Status verified
Dec 2024
Primary completion
Aug 15, 2026
Completion
Aug 15, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mt. Sinai Medical CenterNew YorkNew York10029
Alexander Kolevzon, MD
[email protected]
212-659-8752
Catherine Sancimino, PhD
[email protected]
Golisano Center for Special NeedsSyracuseNew York13210
Henry S Roane, PhD
[email protected]
315-464-3555

Find similar trials in New York, NY

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Mt. Sinai Medical Center· New York, NYGolisano Center for Special Needs· Syracuse, NY

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