Transcranial Photobiomodulation for Reducing Autism Symptoms in Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2023-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Randomized, Placebo-controlled, Double Blind, Mixed Design study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Cognilum TM: Light Treatment Condition

Intervention Type DEVICE

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.

Group Type PLACEBO_COMPARATOR

Cognilum TM: Light Treatment Condition

Intervention Type DEVICE

The children will wear the CognilumTM device for up to 15 minutes at a time, twice a week, for a period of 8 weeks.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No