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Transcranial Photobiomodulation for Reducing Autism Symptoms in Children (TPBMASD)

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ClinicalTrials.gov Identifier: NCT04660552
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
JelikaLite LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Device: Cognilum TM: Light Treatment Condition Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Randomized, Placebo-controlled, Double Blind, Mixed Design study
Masking: Triple (Participant, Care Provider, 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 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.
Primary Purpose: Treatment
Official Title: Transcranial Photobiomodulation for Reducing Autism Symptoms in Children
Actual Study Start Date : November 15, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: Cognilum TM: Light Treatment Condition
The children will wear the CognilumTM device for approximately 15 minutes at a time, twice a week, for a period of 8 weeks.
Placebo Comparator: 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.
 Device: Cognilum TM: Light Treatment Condition
The children will wear the CognilumTM device for approximately 15 minutes at a time, twice a week, for a period of 8 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Autism symptoms [ Time Frame: 8 weeks ]
    Significant change of total score on a Childhood Autism Rating Scales in the experimental condition but not in the control condition (measured by ANOVA)

  2. EEG - 1 [ Time Frame: 8 weeks ]
    Absolute power spectrum alterations will be measured in all oscillatory frequency bands (e.g. Alpha, Beta, Gamma, Delta, Theta, etc.) .

  3. EEG - 2 [ Time Frame: 8 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

    -

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04660552


Contacts
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Contact: Katya Sverdlov, Esq. 19175668151 katya@jelikalite.com
Contact: Eugenia Steingold, PhD 8576360893 dr.eugenia.steingold@gmail.com

Locations
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United States, New York
Dr. Steingold Psychology PC Recruiting
Brooklyn, New York, United States, 11229
Contact: Katya Sverdlov, Esq.    917-566-8151    katya@jelikalite.com   
Contact: Eugenia Steingold, PhD    8576360893    dr.eugenia.steingold@gmail.com   
Principal Investigator: Yuli Fradkin, MD         
Dr. Steingold Psychology PC Recruiting
New York, New York, United States, 10019
Contact: Katya Sverdlov, Esq.    917-566-8151    katya@jelikalite.com   
Contact: Eugenia Steingold, PhD    8576360893    dr.eugenia.steingold@gmail.com   
Sponsors and Collaborators
JelikaLite LLC
Investigators
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Principal Investigator: Yuli Fradkin, MD RDT Group NJ
More Information
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Publications:

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Responsible Party: JelikaLite LLC
ClinicalTrials.gov Identifier: NCT04660552    
Other Study ID Numbers: 19751975
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data (IPD) will be available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
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.: No
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders