Trial Outcomes & Findings for Transcranial Photobiomodulation for Reducing Autism Symptoms in Children - Open Label Study (TPBMASDOL) (NCT NCT06359080)

NCT ID: NCT06359080

Last Updated: 2024-06-06

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: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: 10 weeks
• Results posted on: 2024-06-06

Participant Flow

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 10 weeks.
Overall Study STARTED	25
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	3

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 10 weeks.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Transcranial Photobiomodulation for Reducing Autism Symptoms in Children - Open Label Study (TPBMASDOL)

Baseline characteristics by cohort

Measure	CognilumTM n=22 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 10 weeks.
Age, Continuous	4.9 years STANDARD_DEVIATION 1.46 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants
Childhood Autism Rating Scales, Second Edition (CARS, 2nd Edition)	36.45 units on a scale STANDARD_DEVIATION 5.55 • n=5 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: The study enrolled children of both sexes aged two to seven 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 10 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.

Outcome measures

Measure	CognilumTM n=22 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 10 weeks.
Change in Autism Symptoms	-6.77 units on a scale Standard Deviation 3.38

Adverse Events

CognilumTM

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 Operating Officer

JelikaLite Corp

Phone: 9175668151

Email: katya@jelikalite.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place