Safety and Efficacy of tPBM for Epileptiform Activity in Autism
NCT ID: NCT06352372
Last Updated: 2025-07-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-07-01
Study Completion Date
2026-06-30
Brief Summary
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For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. 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.
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Detailed Description
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Conditions
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Autism Spectrum Disorder
EEG With Periodic Abnormalities
Epilepsy
Neurodevelopmental Disorders
Neurological Disorder
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
This is a prospective, open label study comparing 15 individuals with active seizures and 15 individuals with EEG abnormalities before and after treatment with, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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 and the second arm will receive a placebo (no intervention).
Group Type
EXPERIMENTAL
noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
Intervention Type
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.
Interventions
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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.
Intervention Type
DEVICE
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
4 Years
Maximum Eligible Age
12 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Richard Frye
OTHER
Sponsor Role
lead
Responsible Party
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Richard Frye
Principal Investigator and Sponsor
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Richard E Frye, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Rossignol Medical Center, Phoenix AZ
Locations
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Rossignol Medical Center
Phoenix, Arizona, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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tPBM Study
Identifier Type: -
Identifier Source: org_study_id
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