Autism Spectrum Disorder
Conditions
Keywords
Transcranial photobiomodulation, Autism Spectrum Disorder
Brief summary
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
The children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks.
Sponsors
JelikaLite LLC
Mt. Sinai School of Medicine, New York, New York
MetroEHS
State University of New York - Upstate Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention model description
This is a Randomized, Sham-controlled, Double Blind, Mixed-Design study
Eligibility
Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. Raw scores may range from 15 to 60, which are then converted to T-scores. Higher scores indicate greater severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 disorders. Raw scores may range from 65 to 260, which are then converted to T-scores. Higher scores indicate greater severity. |
| 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. Ratings range from 1 (Normal) to 7 (Among the most severe). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical Interviews | 10 weeks | Caregiver interviews obtaining information on the participant's functioning. |
| Sensory Profile Caregiver Questionnaire -- Second Edition | 10 weeks | Assessment of sensory needs |
| Aberrant Behavior Checklist | 10 weeks | Behavior assessment |
| Repetitive Behavior Scale | 10 weeks | Assessment of restricted and repetetive behaviors |
Countries
United States
Contacts
Primary ContactWilliam E Sullivan, PhD
Backup ContactHenry S Roane, PhD
Outcome results
None listed