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

Autism Spectrum Disorder Clinical Trial

Official title:

Transcranial Photobiomodulation for Reducing Autism Symptoms in Children.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06359080
• Other study ID #: 120200004OL
• Status: Completed
• Phase: N/A
• Start date: May 8, 2022
• Est. completion date: December 11, 2022

Study information

• Verified date: April 2024
• Source: JelikaLite LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 11, 2022
• Est. primary completion date: December 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Dr. Steingold Psychology PC	Brooklyn	New York
United States	Dr. Steingold Psychology PC	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
JelikaLite LLC

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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