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Light Therapy

Light Therapy for Autism (TPBMASD Trial)

N/A
Waitlist Available
Led By Yuli Fradkin, MD
Research Sponsored by JelikaLite LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

TPBMASD Trial Summary

This trial will test if a treatment called transcranial photobiomodulation can help reduce symptoms of autism in young children.

Who is the study for?
This trial is for children aged 2-6 with moderate to severe autism. They can participate even if they have another psychiatric disorder, as long as it's not excluded, and are allowed to continue behavioral therapies during the study. Parents must understand the study and consent.Check my eligibility
What is being tested?
The trial tests whether transcranial photobiomodulation (light therapy) can reduce autism symptoms in children. It involves light treatment twice a week for 8 weeks, with results measured by interviews, CARS scores, and EEG data.See study design
What are the potential side effects?
Potential side effects of transcranial photobiomodulation are not detailed in this summary but may include discomfort at the site of application or changes in mood or behavior; however, these should be monitored closely.

TPBMASD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Most of the participants in both the control and experimental groups are likely to be receiving behavioral therapies
Select...
It's okay if you're receiving behavioral therapy while participating in the study. The analysis will take into account the participants receiving therapy in both the control and experimental groups. The study found no problems or conflicts between the therapy and the treatment being studied.

TPBMASD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Autism symptoms
EEG - 1
EEG - 2

TPBMASD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CognilumTMExperimental Treatment1 Intervention
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.
Group II: Placebo conditionPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

JelikaLite LLCLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
40 Patients Enrolled for Autism Spectrum Disorder
Yuli Fradkin, MDPrincipal InvestigatorRDT Group NJ

Media Library

Cognilum TM (Light Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04660552 — N/A
Autism Spectrum Disorder Research Study Groups: CognilumTM, Placebo condition
Autism Spectrum Disorder Clinical Trial 2023: Cognilum TM Highlights & Side Effects. Trial Name: NCT04660552 — N/A
Cognilum TM (Light Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04660552 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants younger than 45 years of age eligible for this research?

"As per the inclusion criteria for this medical study, only those between 2 and 6 years of age are eligible. The trial boasts 228 studies that involve children under 18-years-old and 42 research projects focusing on patients over 65."

Answered by AI

What criteria must an individual fulfill to participate in this research project?

"This autism spectrum disorder study is seeking 30 participants aged between 2 and 6 years old."

Answered by AI

What is the total population for this medical trial's enrollment?

"Affirmative. The clinicaltrial.gov website shows that this research study, which was initially announced on November 15th 2020, is still looking for applicants. A total of 30 people are needed across 2 different medical facilities."

Answered by AI

Are new participants being accepted into the trial at this time?

"As per the information on clinicaltrials.gov, this medical experiment is actively seeking participants and has been open for application since November 15th 2020 with its most recent update following shortly after on December 7th of that same year."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
Pennsylvania
New York
How old are they?
< 18
18 - 65
What site did they apply to?
Dr. Steingold Psychology PC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Dr. Steingold Psychology PC: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
~7 spots leftby Mar 2025