Safety and Efficacy of tPBM for Epileptiform Activity in Autism

Richard Frye

Status and phase: Enrolling; Phase 2

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

Treatments: Device: noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)

Study type: Interventional

Funder types: Other

Identifiers

NCT06352372

tPBM Study

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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 &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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

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

Experimental group

Description:

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).

Treatment:

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