Safety and Efficacy of tPBM for Epileptiform Activity in Autism

Phase 2

Recruiting

• Conditions: EEG With Periodic Abnormalities; Neurological Disorder; Neurodevelopmental Disorders; Autism Spectrum Disorder; Epilepsy
• Interventions: Device: noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)

• Registration Number: NCT06352372
• Lead Sponsor: Richard Frye

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-04-04
• Study First Posted: 2024-04-08
• Status Verified: 2024-07
• Study Start: 2024-07-01
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brain of autistic child	noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)	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).

Primary Outcome Measures

Name	Time	Method
Childhood Autism Rating Scores (CARS)	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.

Secondary Outcome Measures

Name	Time	Method
EEG Delta Power	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

Trial Locations

Locations (1)

Rossignol Medical Center; 🇺🇸 Phoenix, Arizona, United States