Recruiting

PhotoBioModulation

Sponsor:

Cynthia Kerson

Code:

NCT07509177

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Photobiomodulation

Study Details

Brief summary:

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.

Conditions

Epilepsy

Study ID

NCT07509177

Start date

Aug 11, 2025

Status verified date

Apr, 2026

Completion date

Aug 11, 2027

Anticipated

Primary completion date

Aug 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

\-

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active photobiomodulation sessions

Participants 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 sessions

One 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.

Interventions

Photobiomodulation

Transcranial 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.

Primary outcome measure

  • Subjective level of stress [ Time Frame: Start to post-intervention to 6-month follow-up ]

Central Contacts and Locations

Central contacts

Cynthia Kerson, PhD

415-515-3243ckerson@saybrook.edu

Stephanie Ryall, MS

513-667-2165steph@rightmindwellnesscenter.org

Locations

Brain Health Center Miami

Recruiting

North Miami, Florida, United States, 33162

Contacts

Natasha Nesic, Co-Investigator, MA

786-333-9097natashanesic@gmail.com

Cynthia Kerson, Principal Investigator, PhD

415-515-3243ckerson@saybrook.edu

Right Mind Wellness Center

Recruiting

Cincinnati, Ohio, United States, 45227

Contacts

Stephanie Ryall, MA

513-667-2165steph@rightmindwellnesscenter.org

Cynthia Kerson, PhD

415-515-3243ckerson@saybrook.edu

Holly Maggiano, MD

Recruiting

Warren, Ohio, United States, 44484

Contacts

Sue Joy, RN

330-307-0244suejoy417@gmail.com

Cynthia Kerson, PhD

4155153243ckerson@saybrook.edu

Houston Neuroscience Brain Center

Recruiting

Houston, Texas, United States, 77098

Contacts

Alexandra Roark, Co-Invetsigator, MA

512-708-5551alexandra@hnbraincenter.com

Cynthia Kerson, PhD

415-515-3243ckerson@saybrook.edu

More Information

Sponsor

Cynthia Kerson

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Epilepsy
  • Stress
  • Photobiomodulation
  • Metabolic Testing
  • PBM

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Cynthia Kerson on 2026-04-23.