Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognilum TM: Light Treatment Condition.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 2 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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 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.
Interventions
- 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.
Primary outcome measures
- Childhood Autism Rating Scale, Second edition [Time frame: 10 weeks]
Secondary outcome measures (2)
- Social Responsiveness Scale, Second Edition [Time frame: 10 weeks]
- Clinical Global Impressions Scale [Time frame: 10 weeks]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Mt. Sinai Medical Center — New York
- Golisano Center for Special Needs — Syracuse
Identifiers
NCT: NCT06006637 · 2041726 · 111111