Epilepsy Clinical Trials

Find Epilepsy Clinical Trials Near You

Photobiomodulation Radiant Intervention for Stress in Epilepsy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• • \>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

Locations
United States
Ohio
Right Mind Wellness Center
RECRUITING
Cincinnati
Contact Information
Primary
Cynthia Kerson, PhD
ckerson@saybrook.edu
415-515-3243
Backup
Stephanie Ryall, MS
steph@rightmindwellnesscenter.org
513-667-2165
Time Frame
Start Date: 2025-08-11
Estimated Completion Date: 2027-08-11
Participants
Target number of participants: 80
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Cynthia Kerson

This content was sourced from clinicaltrials.gov