Safety and Efficacy of tPBM for Epileptiform Activity in Autism

Last updated: July 21, 2025
Sponsor: Richard Frye
Overall Status: Active - Recruiting

Phase

2

Condition

Essential Tremor

Tourette's Syndrome

Metachromatic Leukodystrophy - Mld

Treatment

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

Clinical Study ID

NCT06352372
tPBM Study
  • Ages 4-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or theADI-R).

  • Between 4 and 12 years of age, at baseline.

  • Autism severity of moderate or higher (≥4) under the 7-item clinical globalimpression-severity scale. Moderate level of autism severity (4) is defined by thediagnosis of ASD with language impairment.

  • Ability to maintain all ongoing complementary, dietary, traditional, and behavioraltreatments constant for the study period.

  • Unchanged complementary, dietary, traditional, and behavioral treatments for twomonths 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

Exclusion Criteria:

  • Significant self-abusive or violent behavior or evidence of suicidal ideation, planor behavior

  • Severely affected children as defined by CGI-Severity Standard Score = 7 (ExtremelyIll)

  • Severe prematurity (<34 weeks gestation) as determined by medical history

  • Current uncontrolled gastroesophageal reflux disease since GERD can cause movementsthat appear like seizures

  • Genetic syndromes

  • Congenital brain malformations

  • Any medical condition that the PI determines could jeopardize the safety of thestudy 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

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
Phase: 2
Study Start date:
July 01, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Rossignol Medical Center

    Phoenix, Arizona 85050
    United States

    Active - Recruiting

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