Photobiomodulation for Autism (tPBM Trial)

Phase 2

Recruiting

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

No Placebo-Only Group

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Childhood Autism Rating Scores (CARS)

Secondary study objectives

EEG Delta Power

Other study objectives

Clinical Global Impression Scale (CGI)

NIH Toolbox

Seizure frequency and severity

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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