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Transcranial Photobiomodulation for Reducing Autism Symptoms in Children (TPBMASD)

Primary Purpose

Autism Spectrum Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognilum TM: Light Treatment Condition

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female participants between 2 years and 6 years of age (inclusive), of all races.
Previously diagnosed with moderate or severe ASD by a licensed professional.
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.
Parents of participants must understand the nature of the study.
Parents of participants must sign an IRB- approved informed consent form before initiation of any study procedures.
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.
Participant child experiencing a major psychiatric disorder will be allowed to participate in the study provided they do not meet any exclusionary criteria.
The participant child is willing to participate in this study.

Exclusion Criteria:

Participant child is experiencing severe self-injurious behavior or severe aggressive behavior to self or others (within past 7 days).
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.
Participant has an unstable medical condition (that requires clinical attention).
Participant has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo).
Participant has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve).
Participant has receiving medication on a regular basis for Autism or any other medical condition.
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).
Current treatment with a psychotropic medication.
Investigator and his/her immediate family, defined as the investigator's child or grandchild.
-

Sites / Locations

Dr. Steingold Psychology PCRecruiting
Dr. Steingold Psychology PCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CognilumTM

Placebo condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Autism symptoms

Significant change of total score on a Childhood Autism Rating Scales in the experimental condition but not in the control condition (measured by ANOVA)

EEG - 1

Absolute power spectrum alterations will be measured in all oscillatory frequency bands (e.g. Alpha, Beta, Gamma, Delta, Theta, etc.) .

EEG - 2

The power spectrum across all electrodes for each oscillatory frequency band will be averaged, and the ratio of post- over pre-session rest-EEG for both active and sham conditions will be compared.

Secondary Outcome Measures

Full Information

NCT ID

NCT04660552

First Posted

November 16, 2020

Last Updated

December 7, 2020

Sponsor

JelikaLite LLC

1. Study Identification

Unique Protocol Identification Number

NCT04660552

Brief Title

Transcranial Photobiomodulation for Reducing Autism Symptoms in Children

Acronym

TPBMASD

Official Title

Transcranial Photobiomodulation for Reducing Autism Symptoms in Children

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Recruiting

Study Start Date

November 15, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

JelikaLite LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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 CARS (Childhood Autism Rating Scales) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigator

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 CARS. 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.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CognilumTM

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo condition

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Cognilum TM: Light Treatment Condition

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Autism symptoms

Description

Significant change of total score on a Childhood Autism Rating Scales in the experimental condition but not in the control condition (measured by ANOVA)

Time Frame

8 weeks

Title

EEG - 1

Description

Absolute power spectrum alterations will be measured in all oscillatory frequency bands (e.g. Alpha, Beta, Gamma, Delta, Theta, etc.) .

Time Frame

8 weeks

Title

EEG - 2

Description

The power spectrum across all electrodes for each oscillatory frequency band will be averaged, and the ratio of post- over pre-session rest-EEG for both active and sham conditions will be compared.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female participants between 2 years and 6 years of age (inclusive), of all races. Previously diagnosed with moderate or severe ASD by a licensed professional. 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. Parents of participants must understand the nature of the study. Parents of participants must sign an IRB- approved informed consent form before initiation of any study procedures. 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. Participant child experiencing a major psychiatric disorder will be allowed to participate in the study provided they do not meet any exclusionary criteria. The participant child is willing to participate in this study. Exclusion Criteria: Participant child is experiencing severe self-injurious behavior or severe aggressive behavior to self or others (within past 7 days). 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. Participant has an unstable medical condition (that requires clinical attention). Participant has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo). Participant has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve). Participant has receiving medication on a regular basis for Autism or any other medical condition. 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). Current treatment with a psychotropic medication. Investigator and his/her immediate family, defined as the investigator's child or grandchild. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katya Sverdlov, Esq.

Phone

19175668151

katya@jelikalite.com

First Name & Middle Initial & Last Name or Official Title & Degree

Eugenia Steingold, PhD

Phone

8576360893

dr.eugenia.steingold@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuli Fradkin, MD

Organizational Affiliation

RDT Group NJ

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr. Steingold Psychology PC

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katya Sverdlov, Esq.

Phone

917-566-8151

katya@jelikalite.com

First Name & Middle Initial & Last Name & Degree

Eugenia Steingold, PhD

Phone

8576360893

dr.eugenia.steingold@gmail.com

First Name & Middle Initial & Last Name & Degree

Yuli Fradkin, MD

Facility Name

Dr. Steingold Psychology PC

City

New York

State/Province

New York

ZIP/Postal Code

10019

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katya Sverdlov, Esq.

Phone

917-566-8151

katya@jelikalite.com

First Name & Middle Initial & Last Name & Degree

Eugenia Steingold, PhD

Phone

8576360893

dr.eugenia.steingold@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No individual participant data (IPD) will be available to other researchers

Citations:

PubMed Identifier

29717196

Citation

Bosl WJ, Tager-Flusberg H, Nelson CA. EEG Analytics for Early Detection of Autism Spectrum Disorder: A data-driven approach. Sci Rep. 2018 May 1;8(1):6828. doi: 10.1038/s41598-018-24318-x.

Results Reference

background

PubMed Identifier

27752476

Citation

Hamblin MR. Shining light on the head: Photobiomodulation for brain disorders. BBA Clin. 2016 Oct 1;6:113-124. doi: 10.1016/j.bbacli.2016.09.002. eCollection 2016 Dec.

Results Reference

background

PubMed Identifier

26346298

Citation

Henderson TA, Morries LD. Near-infrared photonic energy penetration: can infrared phototherapy effectively reach the human brain? Neuropsychiatr Dis Treat. 2015 Aug 21;11:2191-208. doi: 10.2147/NDT.S78182. eCollection 2015.

Results Reference

background

PubMed Identifier

21851183

Citation

Khuman J, Zhang J, Park J, Carroll JD, Donahue C, Whalen MJ. Low-level laser light therapy improves cognitive deficits and inhibits microglial activation after controlled cortical impact in mice. J Neurotrauma. 2012 Jan 20;29(2):408-17. doi: 10.1089/neu.2010.1745. Epub 2011 Sep 21.

Results Reference

background

PubMed Identifier

29956199

Citation

Leisman G, Machado C, Machado Y, Chinchilla-Acosta M. Effects of Low-Level Laser Therapy in Autism Spectrum Disorder. Adv Exp Med Biol. 2018;1116:111-130. doi: 10.1007/5584_2018_234.

Results Reference

background

PubMed Identifier

19043581

Citation

Weissman JR, Kelley RI, Bauman ML, Cohen BH, Murray KF, Mitchell RL, Kern RL, Natowicz MR. Mitochondrial disease in autism spectrum disorder patients: a cohort analysis. PLoS One. 2008;3(11):e3815. doi: 10.1371/journal.pone.0003815. Epub 2008 Nov 26.

Results Reference

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Transcranial Photobiomodulation for Reducing Autism Symptoms in Children

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