Trials / Completed
CompletedNCT06352372
Safety and Efficacy of tPBM for Epileptiform Activity in Autism
Safety and Efficacy of Transcranial Photobiomodulation (tPBM) for Individuals With Autism Spectrum Disorder and Epileptiform Activity
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Richard Frye · Academic / Other
- Sex
- All
- Age
- 4 Years – 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Autism Spectrum Disorder
- EEG With Periodic Abnormalities
- Epilepsy
- Neurodevelopmental Disorders
- Neurological Disorder
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-07-01
- Primary completion
- 2026-02-10
- Completion
- 2026-02-10
- First posted
- 2024-04-08
- Last updated
- 2026-02-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06352372. Inclusion in this directory is not an endorsement.