Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-17

Study Completion Date

2026-08-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Randomized, Sham-controlled, Double Blind, Mixed-Design study

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Cognilum TM: Light Treatment Condition

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

Cognilum TM: Light Treatment Condition

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

2 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No