An Examination of Whether Infrared Light Therapy Can Reduce Stress in People With Epilepsy
Part of paid clinical trials in North Miami, Florida.
- Sponsor
- Cynthia Kerson
- Study ID
- NCT07509177
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Photobiomodulation — OTHERTranscranial photobiomodulation emits low light (infrared) through the scalp and energizes mitochondria, which in turn produce more energy. It is assumed that many brain-related disorders are afflicted with this phenomenon.
Study Details
Do you have Epilepsy? Would you like to participate in a study using PhotoBioModulation (PBM)? PBM is being researched for potential benefits in resolving many stress-related brain disorders. It is a non-invasive technique that delivers light energy to cells and tissues that can promote brain stabilization and self-regulation, cell repair, reduce oxidative stress, and enhance cellular function. We ask you to participate for about 3-4 months and come to our facility for 30 minute sessions 3x a week for 15 weeks. You will receive extensive metabolic testing and an Õura ring for your participation.
Key Dates
- Start date
- Aug 11, 2025
- Status verified
- Apr 2026
- Primary completion
- Aug 11, 2026
- Completion
- Aug 11, 2027
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Active photobiomodulation sessionsParticipants will undergo 45 20-minute sessions of photobiomodulation. All other aspects of the study will be the same as the sham group. The Vielight Pro 2 PBM system we'll be using for this study emits pulsed 810nm near infra-red light through the nasal passage and cranium. It is a helmet that is placed on the head, and a light emitter is clipped onto the nostril. The participant will sit comfortably in a dimly-lit room, allow the helmet to be placed on their head and clip to be placed on the nostril (see below). The sessions last 20 minutes. They can read, listen to music, write, or draw during the session.
- Sham Comparator: Control photobiomodulation sessionsOne third of the participants will undergo 45 20-minute 'fake' photobiomodulation sessions. All other aspects of the study will be the same as the active group.
Primary Outcome Measure
Subjective level of stress [ Time Frame: Start to post-intervention to 6-month follow-up ]
Central Contacts
- Cynthia Kerson, PhD415-515-3243
- Stephanie Ryall, MS513-667-2165
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brain Health Center Miami | North Miami | Florida | 33162 | |
| Right Mind Wellness Center | Cincinnati | Ohio | 45227 | |
| Holly Maggiano, MD | Warren | Ohio | 44484 | |
| Houston Neuroscience Brain Center | Houston | Texas | 77098 |
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