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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: Completed Phase 2 study, sponsored by Richard Frye.
NCT06352372 is a Phase 2 study that has completed, run by Richard Frye. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60.
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 |
What the finished NCT06352372 record still lists
NCT06352372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06352372's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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