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

Sponsor

State University of New York - Upstate Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06006637

Collaborator

JelikaLite LLC (Industry)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Device: Cognilum TM: Light Treatment Condition	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

Anticipated Study Start Date :

Aug 15, 2023

Anticipated Primary Completion Date :

Aug 15, 2024

Anticipated Study Completion Date :

Aug 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: 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.
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.	Device: 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.

Arm

Intervention/Treatment

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.

Device: 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.

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.

Device: 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.

Outcome Measures

Primary Outcome Measures

Childhood Autism Rating Scale, Second edition [10 weeks]
Psychometrically sound measure for identifying children with autism and their symptom severity through quantifiable ratings based on direct observation.

Secondary Outcome Measures

Social Responsiveness Scale, Second Edition [10 weeks]
Psychometrically sound measure for identifying the presence and severity of social impairment within the autism spectrum and differentiates it from that which occurs in other disorder.
Clinical Global Impressions Scale [10 weeks]
A well-established, brief assessment of the clinician's view of the patient's global functioning prior to and after initiating intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 8 Years

Sexes Eligible for Study:

All

Accepts 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 medications on a regular basis
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

State University of New York - Upstate Medical University
JelikaLite LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

State University of New York - Upstate Medical University

ClinicalTrials.gov Identifier:

NCT06006637

Other Study ID Numbers:

2041726
111111

First Posted:

Aug 23, 2023

Last Update Posted:

Aug 23, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by State University of New York - Upstate Medical University

Transcranial photobiomodulation

Autism Spectrum Disorder

Additional relevant MeSH terms:

Autistic Disorder

Autism Spectrum Disorder

Child Development Disorders, Pervasive

Study Results

No Results Posted as of Aug 23, 2023