Safety and Efficacy of tPBM for Epileptiform Activity in Autism (tPBM)

April 22, 2026 updated by: Richard Frye

Safety and Efficacy of Transcranial Photobiomodulation (tPBM) for Individuals With Autism Spectrum Disorder and Epileptiform Activity

For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children with abnormal EEGs with epileptiform discharges or with epilepsy. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • Rossignol Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R).
  • Between 4 and 12 years of age, at baseline.
  • Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. Moderate level of autism severity (4) is defined by the diagnosis of ASD with language impairment.
  • Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period.
  • Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry
  • Ability to tolerate procedures, as determined at the discretion of the investigator.
  • At least one 24hr EEG with data in EDF format that is accessible to investigators.

Exclusion Criteria:

  • Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior
  • Severely affected children as defined by CGI-Severity Standard Score = 7 (Extremely Ill)
  • Severe prematurity (<34 weeks gestation) as determined by medical history
  • Current uncontrolled gastroesophageal reflux disease since GERD can cause movements that appear like seizures
  • Genetic syndromes
  • Congenital brain malformations
  • Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data.
  • Failure to thrive or Body Mass Index < 5%ile or <5%ile for weight (male <11.2kg; female <10.8kg by CDC 2000 growth charts) at the time of the study.

  • Concurrent treatment with drug that would significantly interact with treatment.

    • • Stimulants
    • • Anti-Psychotics
    • • Antihistamines
  • Excessive Hair that the caregivers are unwilling or unable to shave or braid.
  • Inability to tolerate the required dosage of tPBM treatment due to sensory issues.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brain of autistic child
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
Device: noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
The proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childhood Autism Rating Scores (CARS)
Time Frame: Baseline, Week 11 and Week 15 (One Month Follow-Up)
The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60.
Baseline, Week 11 and Week 15 (One Month Follow-Up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG Delta Power
Time Frame: Before Treatment and EEG following treatment (within 6 months)
Delta power is a measures of the amount of brain activity in the delta frequency as measured by overnight EEG
Before Treatment and EEG following treatment (within 6 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure frequency and severity
Time Frame: Baseline, Week 11 and Week 15 (One Month Follow-Up)
Seizure log will record the seizure severity and frequency
Baseline, Week 11 and Week 15 (One Month Follow-Up)
Social Responsiveness Scale (SRS)
Time Frame: Baseline, Week 11 and Week 15 (One Month Follow-Up)
The SRS is a caregiver report of autism symptoms Lower Score is Better, Scores range from 30 to 90 (T-scores)
Baseline, Week 11 and Week 15 (One Month Follow-Up)
Clinical Global Impression Scale (CGI)
Time Frame: Baseline, Week 11 and Week 15 (One Month Follow-Up)
The CGI measures the overall disease severity and change. It is completed by a clinician. Scores range from 1 to 7. Lower score is better
Baseline, Week 11 and Week 15 (One Month Follow-Up)
NIH Toolbox
Time Frame: Baseline, Week 11 and Week 15 (One Month Follow-Up)
The NIH ToolBox is a set of short assessments for neurodevelopmental assessments. Direction of score depends on individual subtest.
Baseline, Week 11 and Week 15 (One Month Follow-Up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Richard Frye

Investigators

  • Principal Investigator: Richard E Frye, M.D., Ph.D, Rossignol Medical Center, Phoenix AZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

February 10, 2026

Study Completion (Actual)

February 10, 2026

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tPBM Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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