Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

— IPMR ASD  

Official title:

Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06006637
• Other study ID #: 2041726
• Secondary ID: 111111
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: October 2023
• Source: State University of New York - Upstate Medical University
• Contact: William E Sullivan, PhD
• Phone: 315-464-3932
• Email: sullivaw[@]upstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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).

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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.

Locations

Country	Name	City	State
United States	Golisano Center for Special Needs	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University	JelikaLite LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Social Responsiveness Scale, Second Edition	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 disorders. Raw scores may range from 65 to 260, which are then converted to T-scores. Higher scores indicate greater severity.	10 weeks
Secondary	Clinical Global Impressions Scale	A well-established, brief assessment of the clinician's view of the patient's global functioning prior to and after initiating intervention. Ratings range from 1 (Normal) to 7 (Among the most severe).	10 weeks