Trial Outcomes & Findings for Transcranial Photobiomodulation for Reducing Autism Symptoms in Children (NCT NCT04660552)

Last Updated: 2024-06-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

8 weeks

Results posted on

2024-06-03

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	19	15
Overall Study COMPLETED	16	14
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Transcranial Photobiomodulation for Reducing Autism Symptoms in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CognilumTM n=16 Participants 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.	Placebo Condition n=14 Participants 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.	Total n=30 Participants Total of all reporting groups
Age, Continuous	4.9 years STANDARD_DEVIATION 1.25 • n=5 Participants	4.6 years STANDARD_DEVIATION 1.16 • n=7 Participants	4.6 years STANDARD_DEVIATION 1.21 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Childhood Autism Rating Scales, Second Edition (CARS, 2nd Edition)	43.5 units on a scale STANDARD_DEVIATION 5.7 • n=5 Participants	40.6 units on a scale STANDARD_DEVIATION 7.2 • n=7 Participants	43.5 units on a scale STANDARD_DEVIATION 6.46 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CognilumTM n=16 Participants 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.	Placebo Condition n=14 Participants 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.
Change in Autism Symptoms	-9.87 score on a scale Standard Deviation 4.19	-2.64 score on a scale Standard Deviation 7.99

Adverse Events

CognilumTM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katya Sverdlov, Chief Executive Officer

JelikaLite Corp

Phone: 9175668151

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place