Infrared (photobiomodulation) light therapy to reduce stress in people with epilepsy
Photobiomodulation Radiant Intervention for Stress in Epilepsy
This program tests whether infrared photobiomodulation (PBM) can lower stress in adults with epilepsy by delivering 30-minute light therapy sessions three times a week for about 15 weeks, along with metabolic testing and continuous Oura ring monitoring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saybrook University Academic / other |
| Locations | 4 sites (North Miami, Florida and 3 other locations) |
| Trial ID | NCT07509177 on ClinicalTrials.gov |
What this trial studies
This interventional program uses photobiomodulation (PBM), a noninvasive infrared light technique, delivered in 30-minute sessions three times per week for approximately 15 weeks (45 sessions total). Participants undergo baseline, post-treatment, and six-month follow-up assessments plus extensive metabolic testing, and wear an Oura ring continuously for activity and sleep monitoring. The protocol requires participants to maintain or only reduce antiseizure medications as directed by their prescriber and excludes those with recent acute brain injury, brain implants, certain toxicities, substance use, or prior neuromodulation. The intervention is offered at a small number of outpatient brain health centers and is positioned as a potential adjunct to existing epilepsy care.
Who should consider this trial
Good fit: Adults aged 18 or older with a medical diagnosis of epilepsy and at least one seizure in the past six months who can attend 45 PBM sessions, undergo metabolic testing, and wear an Oura ring are ideal candidates.
Not a fit: People under 18, those with recent acute traumatic brain injury, current brain bleed, brain implants or pumps, active substance use, certain toxicities, or a history of neuromodulation are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce perceived stress in people with epilepsy and potentially lower stress-related seizure triggers and improve daily functioning.
How similar studies have performed: Photobiomodulation has shown promise in conditions such as anxiety, Parkinson’s disease, pain, and inflammation, but published evidence specifically in epilepsy is limited, making this application relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • \>18 YO * Epilepsy - medical diagnosis with at least one seizure within the past 6 months: diagnosis to be obtained from medical records from the treating physician by signature of HIPAA-compliant medical release form * Agreement to maintain or reduce medication regimen (based upon prescribers' advice) * Available for intake, baseline, post-treatment, 6-month follow-up assessments, and 45 sessions of PBM * Willingness to wear an Õura ring at all times (except for charging) for the duration of the study. Exclusion: * \< 17 YO * Substance use * Personality disorders * Heavy metal toxicity * Mold toxicity * Metabolic measures thresholded based on participant type * Increase in current medication (dosage and/or type) * No new medications prescribed (reduction as prescribed by prescribing physician OK) * Current brain bleed * Acute TBI within the last 12 months * History of neuromodulation, including ECT * Brain implants/pumps/shunts * History of brain surgery * Hormone replacement therapy for menopause or gender transition * Untreated sleep disorders Exclusion Criteria: \-
Where this trial is running
North Miami, Florida and 3 other locations
- Brain Health Center Miami — North Miami, Florida, United States (Recruiting)
- Right Mind Wellness Center — Cincinnati, Ohio, United States (Recruiting)
- Holly Maggiano, MD — Warren, Ohio, United States (Recruiting)
- Houston Neuroscience Brain Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Cynthia Kerson, PhD — Saybrook University
- Study coordinator: Cynthia Kerson, PhD
- Email: ckerson@saybrook.edu
- Phone: 415-515-3243
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.