Safety and Efficacy of tPBM for Epileptiform Activity in Autism

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

Safety and Efficacy of tPBM for Epileptiform Activity in Autism

Condition
Autism Spectrum Disorder
Intervention / Treatment

-

Contacts and Locations

Phoenix

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

4 Years to 12 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Richard Frye,

Richard E Frye, M.D., Ph.D, PRINCIPAL_INVESTIGATOR, Rossignol Medical Center, Phoenix AZ

Study Record Dates

2025-06