Safety and Efficacy of tPBM for Epileptiform Activity in Autism

NCT06352372 | Completed Phase 2 FDA Device

• 1 other identifier: tPBM Study
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Epilepsy; Neurodevelopmental Disorders; Neurological Disorder; EEG With Periodic Abnormalities

Keywords

Autism; Epilepsy; Neurological Disorders; Neurodevelopmental disorders; ASD

Outcome Measures

Primary Outcomes (1)

• Childhood Autism Rating Scores (CARS)

  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 Outcomes (1)

• EEG Delta Power

  Before Treatment and EEG following treatment (within 6 months)

Other Outcomes (4)

• Seizure frequency and severity

  Baseline, Week 11 and Week 15 (One Month Follow-Up)

• Social Responsiveness Scale (SRS)

  Baseline, Week 11 and Week 15 (One Month Follow-Up)

• Clinical Global Impression Scale (CGI)

  Baseline, Week 11 and Week 15 (One Month Follow-Up)

Study Arms (1)

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

EXPERIMENTAL

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)

Interventions

noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) DEVICE

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.

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

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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 \&lt; 5%ile or \&lt;5%ile for weight (male \&lt;11.2kg; female \&lt;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.

Sponsors & Collaborators

• Richard Frye: lead

Study Sites (1)

Rossignol Medical Center

Phoenix, Arizona, 85050, United States

Location

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MeSH Terms

Conditions

Autism Spectrum Disorder; Epilepsy; Neurodevelopmental Disorders; Nervous System Diseases; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders; Brain Diseases; Central Nervous System Diseases

Study Officials

• Richard E Frye, M.D., Ph.D

  Rossignol Medical Center, Phoenix AZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Sponsor

Model Details: This is a prospective, open label study including 15 individuals with active seizures and 15 individuals with EEG abnormalities who will receive the same near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 8, 2024
• Study Start: July 1, 2024
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)