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

NCT06359080 | Completed Results DMC FDA Device

• 1 other identifier: 120200004OL
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Keywords

ASD; Autism; tPBM

Outcome Measures

Primary Outcomes (1)

• Change in Autism Symptoms

  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

Study Arms (1)

CognilumTM

EXPERIMENTAL

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

Interventions

Cognilum TM: Light Treatment Condition DEVICE

The children will wear the CognilumTM device for up to 15 minutes at a time, twice a week, for a period of 10 weeks.

CognilumTM

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female participants between 2 years and 7 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.
• The participant child is willing to participate in this study.
• Participant previously participated in the JelikaLite pivotal clinical trial that took place in 2021, either in the active or placebo conditions.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• JelikaLite LLC: lead

Study Sites (2)

Dr. Steingold Psychology PC

Brooklyn, New York, 11229, United States

Location

Dr. Steingold Psychology PC

New York, New York, 10019, United States

Location

Related Publications (6)

• 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.

  PMID: 29717196 BACKGROUND

• 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.

  PMID: 27752476 BACKGROUND

• 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.

  PMID: 26346298 BACKGROUND

• 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.

  PMID: 21851183 BACKGROUND

• 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.

  PMID: 29956199 BACKGROUND

• 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.

  PMID: 19043581 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Katya Sverdlov, Chief Operating Officer
• Organization: JelikaLite Corp

katya@jelikalite.com

9175668151

Study Officials

• Yuli Fradkin, MD

  RDT Group NJ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label Study This will be an one-arm, open label study. Participants who were in the placebo condition in the previous study, will receive the treatment. Participants who were in the active condition in the previous study will repeat the course of treatment after the intermission of 3-6 months (depending on when they completed the study).

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 11, 2024
• Study Start: May 8, 2022
• Primary Completion: December 11, 2022
• Study Completion: December 11, 2022
• Last Updated: June 6, 2024
• Results First Posted: June 6, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)