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NCT06352372 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of tPBM for Epileptiform Activity in Autism
A Phase 2 study, sponsored by Richard Frye.
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT06352372 is a Phase 2 study that has completed, run by Richard Frye. The registered enrollment target is 6 participants.
The verdict
NCT06352372, a Phase 2 study, has completed, sponsored by Richard Frye.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
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 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.
Interventions
- DEVICE noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2026-02-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06352372
The ClinicalTrials.gov registry entry for NCT06352372 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Richard Frye, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) is the first listed.
NCT06352372 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06352372 about?
NCT06352372 is a clinical study titled "Safety and Efficacy of tPBM for Epileptiform Activity in Autism". 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 li...
What is the current status of trial NCT06352372?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2024-07-01. Estimated completion is 2026-02-10.
What interventions are being tested in trial NCT06352372?
The interventions under investigation include: noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) (DEVICE).
Who is sponsoring clinical trial NCT06352372?
This trial is sponsored by Richard Frye, which has 2 total clinical trials registered on ClinicalTrials.gov.
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