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Photobiomodulation

Near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brain of autistic child for Neurodevelopmental Disorders (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 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).

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Who is running the clinical trial?

Richard FryeLead Sponsor
1 Previous Clinical Trials
1,000 Total Patients Enrolled
1 Trials studying Neurodevelopmental Disorders
1,000 Patients Enrolled for Neurodevelopmental Disorders
Richard E Frye, M.D., Ph.DPrincipal InvestigatorRossignol Medical Center, Phoenix AZ
~20 spots leftby Apr 2025
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