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| ID | Type | Description | Link |
|---|---|---|---|
| 111111 | Other Grant/Funding Number | FUZEhub |
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| Name | Class |
|---|---|
| JelikaLite LLC | INDUSTRY |
| Mt. Sinai School of Medicine, New York, New York | UNKNOWN |
| MetroEHS | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CognilumTM | Experimental | 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. |
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| Sham control | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognilum TM: Light Treatment Condition | Device | The children will wear the CognilumTM device for approximately 10 minutes at a time, twice a week, for a period of 10 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Interviews | Caregiver interviews obtaining information on the participant's functioning. | 10 weeks |
| Aberrant Behavior Checklist | Behavior assessment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William E Sullivan, PhD | Contact | 315-464-3932 | sullivaw@upstate.edu | |
| Henry S Roane, PhD | Contact | 315-464-3555 | roaneh@upstate.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mt. Sinai Medical Center | Recruiting | New York | New York | 10029 | United States |
No individual participant data (IPD) will be available to other researchers
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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This is a Randomized, Sham-controlled, Double Blind, Mixed-Design study
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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.
| 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 |
| 10 weeks |
| Repetitive Behavior Scale | Assessment of restricted and repetetive behaviors | 10 weeks |
| Sensory Profile Caregiver Questionnaire -- Second Edition | Assessment of sensory needs | 10 weeks |
| Golisano Center for Special Needs | Recruiting | Syracuse | New York | 13210 | United States |
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