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

June 4, 2024 updated by: JelikaLite LLC

Transcranial Photobiomodulation for Reducing Autism Symptoms in Children.

The hypothesis of the study is that photobiomodulation reduces symptoms of autism. Participants will be children between the ages of 2 and 7, 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 10 weeks. Results will be measured through parental interviews, standardized CARS2 (Childhood Autism Rating Scales, 2nd Edition) and data collected from EEG.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11229
        • Dr. Steingold Psychology PC
      • New York, New York, United States, 10019
        • Dr. Steingold Psychology PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female participants between 2 years and 7 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.
  9. Participant previously participated in the JelikaLite pivotal clinical trial that took place in 2021, either in the active or placebo conditions.

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. 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).
  7. Current treatment with a psychotropic medication.
  8. Investigator and his/her immediate family, defined as the investigator's child or grandchild.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 up to 15 minutes at a time, twice a week, for a period of 10 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Autism Symptoms
Time Frame: 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.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JelikaLite LLC

Investigators

  • Principal Investigator: Yuli Fradkin, MD, RDT Group NJ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2022

Primary Completion (Actual)

December 11, 2022

Study Completion (Actual)

December 11, 2022

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120200004OL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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