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COMPLETED
NCT06352372
PHASE2

Safety and Efficacy of tPBM for Epileptiform Activity in Autism

Sponsor: Richard Frye

View on ClinicalTrials.gov

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 with abnormal EEGs with epileptiform discharges or with epilepsy. 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.

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

Key Details

Gender

All

Age Range

4 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2024-07-01

Completion Date

2026-02-10

Last Updated

2026-04-24

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (1)

Rossignol Medical Center

Phoenix, Arizona, United States