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Procedure

Light Therapy for Autism (IPMR ASD Trial)

N/A

Recruiting

Research Sponsored by State University of New York - Upstate Medical University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Awards & highlights

IPMR ASD Trial Summary

This trial will test if a light therapy device can help reduce symptoms of autism in children. #Autism #LightTherapy #ClinicalTrial

Who is the study for?

This trial is for children aged 2-8 who have been diagnosed with Autism Spectrum Disorder and have a CARS-2 score between 30 and 45, indicating a certain level of autism symptoms. Details on who cannot participate are not provided.Check my eligibility

What is being tested?

The study tests the effects of transcranial photobiomodulation (tPBM), which uses light treatment called Cognilum TM, on autistic children. It's randomized and double-blind, meaning neither participants nor researchers know who gets real or sham treatment.See study design

What are the potential side effects?

Specific side effects are not listed in the provided information. Generally, tPBM is considered non-invasive but may include discomfort or other reactions at the site of application.

IPMR ASD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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

Childhood Autism Rating Scale, Second edition

Secondary outcome measures

Clinical Global Impressions Scale

Social Responsiveness Scale, Second Edition

IPMR ASD Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CognilumTMExperimental Treatment1 Intervention

During the study participants will be wear the transcranial photobiomodulation device Cognilum. The device will administer the stimulation of near infrared light (830nm) to specific areas of the child's brain.

Group II: Sham controlPlacebo Group1 Intervention

During the study participants will wear the transcranial photobiomodulation device. The device will not be turned on and therefore no brain stimulation with near infrared light (830nm) will be provided.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognilum TM: Light Treatment Condition

2022

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

State University of New York - Upstate Medical UniversityLead Sponsor

173 Previous Clinical Trials

27,352 Total Patients Enrolled

JelikaLite LLCIndustry Sponsor

2 Previous Clinical Trials

52 Total Patients Enrolled

Frequently Asked Questions

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

Are there still openings available for participants in this investigation?

"Yes, the research sponsored by this trial is still actively looking for volunteers. This study was first announced on October 17th 2023 and has since been edited as recently as November 9th of that same year. 40 participants are needed from a single location to complete the project."

Answered by AI

Is the age of prospective participants for this trial limited to individuals under 45 years old?

"This medical trial is looking for participants aged between 2 to 8 years old. The study contains 267 trials specific to minors and 54 trials applicable for those over 65."

Answered by AI

To whom is this study open for enrollment?

"This autism research study is searching for 40 participants aged 2 to 8 with a confirmed diagnosis. Additionally, these patients must have CARS-2 score within the range of 30 to 45 in order to be accepted into the trial."

Answered by AI

What is the maximum number of participants that have been allowed to join this experiment?

"Affirmative, the information available on clinicaltrials.gov implies that this investigation is actively seeking qualifying participants. It was initially posted on October 17th 2023 and subsequently updated on November 9th of the same year. This trial requires 40 individuals to be recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder

2023. "Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06006637.