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Photobiomodulation

Near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brain of autistic child for Epilepsy (tPBM Trial)

Phase 2

Waitlist Available

Led By Richard E Frye, M.D., Ph.D

Research Sponsored by Richard Frye

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 baseline, week 11 and week 15 (one month follow-up)

Awards & highlights

tPBM Trial Summary

This trial involves using a wearable device that emits near infra-red light to treat autistic children's brains. The treatment will be given twice a week for 10 weeks. The expected outcomes include improvements in focus

Who is the study for?

This trial is for autistic children who may experience epileptiform activity. It's important that participants have a diagnosis of autism and are able to attend twice-weekly sessions for 10 weeks. Specific eligibility details aren't provided, but typically, trials like this would exclude those with certain medical conditions or taking conflicting treatments.Check my eligibility

What is being tested?

The study tests if a wearable device called Cognilum can help autistic children by delivering near infra-red light (tPBM) to the brain. The goal is to see if it improves focus, eye contact, speech, behavior, and functional skills over the course of treatment.See study design

What are the potential side effects?

Potential side effects are not detailed in the information provided. However, as tPBM is noninvasive and uses NIR light therapy which generally has minimal risks; any side effects might be mild and could include discomfort at the site of application.

tPBM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 11 and week 15 (one month follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 11 and week 15 (one month follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 11 and week 15 (one month follow-up) 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 Scores (CARS)

Secondary outcome measures

EEG Delta Power

Other outcome measures

Clinical Global Impression Scale (CGI)

NIH Toolbox

Seizure frequency and severity

+1 more

tPBM Trial Design

1Treatment groups

Experimental Treatment

Group I: Near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brain of autistic childExperimental Treatment1 Intervention

This is a prospective, open level study comparing 15 individuals with active seizures and 15 individuals with EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) will be the active arm and the second arm will receive a placebo (no intervention).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Richard FryeLead Sponsor

1 Previous Clinical Trials

1,000 Total Patients Enrolled

1 Trials studying Epilepsy

1,000 Patients Enrolled for Epilepsy

Richard E Frye, M.D., Ph.DPrincipal InvestigatorRossignol Medical Center, Phoenix AZ

Frequently Asked Questions

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

Are individuals still eligible to apply for participation in this ongoing trial?

"As per the information available on clinicaltrials.gov, recruitment for this particular trial has concluded. The initial posting of the study dates back to April 1st, 2024, with the latest update occurring on April 4th, 2024. While this specific study is no longer accepting participants, there are currently a total of 761 other trials actively seeking candidates at present."

Answered by AI

What is the potential risk of using Near-infrared (NIR) light - transcranial Photobiomodulation (tPBM) - on the brain of a child with autism?

"Our evaluation at Power suggests a safety rating of 2 for Near Infra-red (NIR) light - transcranial Photobiomodulation (tPBM) in autistic children's brains. This decision is based on the ongoing Phase 2 trial, where there is evidence supporting its safety but not yet its effectiveness."

Answered by AI

Can individuals who are younger than 65 participate in this research study?

"Eligible candidates for this study must be between 4 and 12 years old. Notably, there are a total of 431 trials available for individuals under the age of 18, alongside 365 trials targeting those above the age of 65."

Answered by AI

Recent research and studies

Behavioral and Brain FunctionsJournal

Psychological Benefits 2 and 4 Weeks After a Single Treatment with Near Infrared Light to the Forehead: A Pilot Study of 10 Patients with Major Depression and Anxiety

Schiffer, Fredric, Andrea L Johnston, Caitlin Ravichandran, Ann Polcari, Martin H Teicher, Robert H Webb, and Michael R Hamblin. 2009. “Psychological Benefits 2 and 4 Weeks After a Single Treatment with Near Infrared Light to the Forehead: A Pilot Study of 10 Patients with Major Depression and Anxiety”. Behavioral and Brain Functions. Springer Science and Business Media LLC. doi:10.1186/1744-9081-5-46.

Advances in Experimental Medicine and BiologyJournal

Effects of Low-level Laser Therapy in Autism Spectrum Disorder

Leisman, Gerry, Calixto Machado, Yanin Machado, and Mauricio Chinchilla-Acosta. 2018. “Effects of Low-level Laser Therapy in Autism Spectrum Disorder”. Advances in Experimental Medicine and Biology. Springer International Publishing. doi:10.1007/5584_2018_234.

Journal of NeurotraumaJournal

Low-level Laser Light Therapy Improves Cognitive Deficits and Inhibits Microglial Activation After Controlled Cortical Impact in Mice

Khuman, Jugta, Jimmy Zhang, Juyeon Park, James D. Carroll, Chad Donahue, and Michael J. Whalen. 2012. “Low-level Laser Light Therapy Improves Cognitive Deficits and Inhibits Microglial Activation After Controlled Cortical Impact in Mice”. Journal of Neurotrauma. Mary Ann Liebert Inc. doi:10.1089/neu.2010.1745.

clinicaltrials.govStudy