An Examination of Whether Infrared Light Therapy Can Reduce Stress in People With Epilepsy

NCT07509177 | Recruiting

• 1 other identifier: 1889
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

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

Keywords

Epilepsy; Stress; Photobiomodulation; Metabolic Testing; PBM

Outcome Measures

Primary Outcomes (1)

• Subjective level of stress

  This study will look at how perceived stress can be moderated with 45 20-minute photobiomodulation sessions and how this affects seizure duration, intensity, and frequency in people with epilepsy, with the Perceived Stress Scale (PSS), and a post score 20% improved from the pre-test score.

  Start to post-intervention to 6-month follow-up

Study Arms (2)

Active photobiomodulation sessions

ACTIVE COMPARATOR

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.

Other: Photobiomodulation

Control photobiomodulation sessions

SHAM COMPARATOR

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.

Other: Photobiomodulation

Interventions

Photobiomodulation OTHER

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.

Also known as: Low light therapy

Active photobiomodulation sessions; Control photobiomodulation sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Cynthia Kerson: lead

Study Sites (4)

Brain Health Center Miami

North Miami, Florida, 33162, United States

RECRUITING

Right Mind Wellness Center

Cincinnati, Ohio, 45227, United States

RECRUITING

Holly Maggiano, MD

Warren, Ohio, 44484, United States

RECRUITING

Houston Neuroscience Brain Center

Houston, Texas, 77098, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Cynthia Kerson, PhD

  Saybrook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Kerson, PhD

CONTACT

415-515-3243; ckerson@saybrook.edu

Stephanie Ryall, MS

CONTACT

513-667-2165; steph@rightmindwellnesscenter.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Statistical analyzer
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 3, 2026
• Study Start: August 11, 2025
• Primary Completion (Estimated): August 11, 2026
• Study Completion (Estimated): August 11, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (4)