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

State University of New York - Upstate Medical University

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Device: Cognilum TM: Light Treatment Condition

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06006637

111111

2041726

Details and patient eligibility

About

This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University with 40 autistic children evaluating the effects of transcranial photobiomodulation (tPBM) on multiple clinically validated scales.

Full 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 with 40 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

CognilumTM

Experimental group

Description:

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.

Treatment:

Device: Cognilum TM: Light Treatment Condition

Sham control

Sham Comparator group

Description:

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.

Treatment:

Device: Cognilum TM: Light Treatment Condition