Autism Spectrum Disorder
Conditions
Brief summary
The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 6, who have been diagnosed with moderate to severe autism. Transcranial photobiomodulation will be administered to the children in the experimental condition twice a week for 8 weeks. Results will be measured through parental interviews, standardized CARS2 (Childhood Autism Rating Scales, 2nd Edition) and data collected from EEG.
Detailed description
The CognilumTM System is a non-invasive device that uses infrared light (IR), delivered through light emitting diodes (LEDs) built into a head band worn by the patient during treatment. The proposed clinical investigation is determined by the FDA to be a nonsignificant risk (NSR) device study.
Interventions
The children will wear the CognilumTM device for up to 15 minutes at a time, twice a week, for a period of 8 weeks.
Sponsors
JelikaLite LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
To minimize the bias, Jelikalight hired an independent pediatric psychiatrist, to act as a PI and supervise the study. The PI is blind (and will remain blind until the end of the study data collection and analysis) to the participants' condition. He will supervise data collection and analysis. The PI will supervise parental interviews. The PI will conduct before and after treatment testing of participants with CARS2. The PI will supervise analysis for raw data. Experimental and control groups will undergo the same experience apart from having the device turned on or turned off during the sessions. The participants (and their parents) will remain blind to their experimental condition, therefore, ensuring double blindness.
Intervention model description
This is a Randomized, Placebo-controlled, Double Blind, Mixed Design study
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female participants between 2 years and 6 years of age (inclusive), of all races. 2. Previously diagnosed with moderate or severe ASD by a licensed professional. 3. Participants may be receiving any behavioral intervention therapy (e.g., ABA, Floor Time) during the course of the treatment. The final statistical analysis will control for the participants receiving behavioral therapies in control and experimental conditions. We expect the majority of the participants in both control and experimental conditions to be receiving behavioral therapies. There is no known interactions or complications of tPBM with behavioral therapy. 4. Parents of participants must understand the nature of the study. 5. Parents of participants must sign an IRB- approved informed consent form before initiation of any study procedures. 6. Parents of participants must have a level of understanding sufficient to communicate with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. 7. Participant child experiencing a major psychiatric disorder will be allowed to participate in the study provided they do not meet any exclusionary criteria. 8. The participant child is willing to participate in this study.
Exclusion criteria
1. Participant child is experiencing severe self-injurious behavior or severe aggressive behavior to self or others (within past 7 days). 2. Participant has been diagnosed with another psychiatric or neurological disorder (e.g. epilepsy) or have exhibited symptoms of major psychiatric disorders within the last 30 days. 3. Participant has an unstable medical condition (that requires clinical attention). 4. Participant has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo). 5. Participant has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve). 6. Participant has receiving medication on a regular basis for Autism or any other medical condition. 7. Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment (in US: Visudine (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid (ALA)- for non-melanoma skin cancer). 8. Current treatment with a psychotropic medication. 9. Investigator and his/her immediate family, defined as the investigator's child or grandchild.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Autism Symptoms | 8 weeks | Childhood Autism Rating Scales, Second Edition (CARS, 2nd Edition), patients were evaluated after conclusion of the study. CARS is a validated clinical rating scale that can be used by a trained clinician to rate items indicative of ASD after direct observation of the child. The scale consists of fifteen items that correspond to the different core domains (e.g., verbal communication, emotional response, and relationships with people) that can be affected by ASD. Total score (sum of all 15 sub-scales) can range from a low of 15 (no ASD) to a high of 60 (severe ASD). For the outcome measure we took the difference between the CARS score at the completion of the study and the CARS score at baseline. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYuli Fradkin, MD
RDT Group NJ
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CognilumTM During the study participants will be wearing the photobiomodulation device Cognilum. The device will administer the stimulation of near infrared light (830nm) to specific areas of the child's brain.
Cognilum TM: Light Treatment Condition: The children will wear the CognilumTM device for up to 15 minutes at a time, twice a week, for a period of 8 weeks. | 16 |
| Placebo Condition During the study participants will be wearing the photobiomodulation device. The device will not be turned on and therefore no brain stimulation with near infrared light (830nm) will be provided.
Cognilum TM: Light Treatment Condition: The children will wear the CognilumTM device for up to 15 minutes at a time, twice a week, for a period of 8 weeks. | 14 |
| Total | 30 |
Baseline characteristics
| Characteristic | CognilumTM | Placebo Condition | Total |
|---|---|---|---|
| Age, Continuous | 4.9 years STANDARD_DEVIATION 1.25 | 4.6 years STANDARD_DEVIATION 1.16 | 4.6 years STANDARD_DEVIATION 1.21 |
| Childhood Autism Rating Scales, Second Edition (CARS, 2nd Edition) | 43.5 units on a scale STANDARD_DEVIATION 5.7 | 40.6 units on a scale STANDARD_DEVIATION 7.2 | 43.5 units on a scale STANDARD_DEVIATION 6.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 14 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Male | 14 Participants | 10 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 14 |
| other Total, other adverse events | 0 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
Change in Autism Symptoms
Childhood Autism Rating Scales, Second Edition (CARS, 2nd Edition), patients were evaluated after conclusion of the study. CARS is a validated clinical rating scale that can be used by a trained clinician to rate items indicative of ASD after direct observation of the child. The scale consists of fifteen items that correspond to the different core domains (e.g., verbal communication, emotional response, and relationships with people) that can be affected by ASD. Total score (sum of all 15 sub-scales) can range from a low of 15 (no ASD) to a high of 60 (severe ASD). For the outcome measure we took the difference between the CARS score at the completion of the study and the CARS score at baseline.
Time frame: 8 weeks
Population: The study enrolled children of both sexes aged two to six years, who had previously been diagnosed with ASD by a licensed professional according to the Diagnostic Statistical Manual of Mental Disorders, Fifth Edition (DSM V).~Every participant was assessed using Childhood Autism Rating Scales, Second Edition (CARS, 2nd Edition).~Participants were evaluated before the course of treatment (baseline) and after the course of treatment. Treatment duration was 8 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CognilumTM | Change in Autism Symptoms | -9.87 score on a scale | Standard Deviation 4.19 |
| Placebo Condition | Change in Autism Symptoms | -2.64 score on a scale | Standard Deviation 7.99 |
p-value: 0.0195% CI: [2.357, 12.107]t-test, 2 sided