80 Participants NeededMy employer runs this trial

Infrared Light Therapy for Epilepsy

(PBM Rise Trial)

Recruiting at 3 trial locations
SR
CK
Overseen ByCynthia Kerson, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cynthia Kerson
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of photobiomodulation (PBM), a type of infrared light therapy, to help manage epilepsy. PBM is non-invasive and aims to stabilize the brain and improve cellular function, potentially reducing seizures and enhancing quality of life. Participants will attend 20-minute sessions three times a week for 15 weeks. The treatment involves using a helmet and light clip that deliver light through the head and nostril. Individuals diagnosed with epilepsy who have experienced at least one seizure in the past six months might be suitable for this study. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options that could enhance quality of life.

Do I have to stop taking my current medications for the trial?

You don't have to stop taking your current medications, but you need to agree to maintain or possibly reduce them based on your doctor's advice. You cannot increase your medication or start new ones during the trial.

What prior data suggests that photobiomodulation is safe for epilepsy?

Research has shown that photobiomodulation (PBM), a type of light therapy, is generally safe and well-tolerated for treating epilepsy. Studies have found that this treatment maintains a strong safety record, with little to no evidence of side effects. As a non-invasive option, it avoids surgery or needles, offering a gentler alternative to other treatments. In human studies, PBM did not cause significant side effects, suggesting its safety for use.12345

Why are researchers excited about this trial?

Researchers are excited about photobiomodulation for epilepsy because it offers a non-invasive approach that uses infrared light to potentially modulate brain activity. Unlike standard treatments like anti-seizure medications, which can have various side effects and require ongoing use, photobiomodulation involves brief sessions where near-infrared light is delivered through a helmet and nasal clip, aiming to influence neural function directly. This method could provide an alternative for individuals who do not respond well to existing medications, offering a new avenue for managing seizures without the side effects associated with pharmaceuticals.

What evidence suggests that photobiomodulation might be an effective treatment for epilepsy?

Research has shown that photobiomodulation (PBM), a type of infrared light therapy, may help reduce seizures in people with epilepsy. Animal studies found that PBM can significantly decrease the frequency and severity of seizures. Although studies on humans provide limited information, early signs suggest that people with epilepsy might experience similar benefits. In this trial, participants will divide into two groups: one receiving active PBM sessions and the other undergoing control (sham) sessions. PBM works by delivering light energy to brain cells, which can enhance their function and repair, possibly leading to more stable brain activity. While more research is needed, PBM is considered a safe and non-invasive treatment option for managing epilepsy.12356

Who Is on the Research Team?

CK

Cynthia Kerson, PhD

Principal Investigator

Saybrook University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with epilepsy who have had at least one seizure in the past 6 months. Participants must be able to attend regular sessions, wear an Õura ring, and keep their medication stable. People with certain medical histories (like brain surgery or implants, substance use issues, or untreated sleep disorders) cannot join.

Inclusion Criteria

Willingness to wear an Õura ring at all times (except for charging) for the duration of the study.
I am able to attend all study visits and complete 45 treatment sessions.
I am over 18 years old.
See 2 more

Exclusion Criteria

History of substance use
History of personality disorders
I am younger than 17 years old.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive photobiomodulation therapy 3 times a week for 45 sessions, lasting 20 minutes each, over a period of 15-20 weeks

15-20 weeks
45 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments and lab work occurring at 6 months post-intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Photobiomodulation

Trial Overview

The study tests whether photobiomodulation—using non-invasive infrared light therapy on the brain—can help reduce stress in people with epilepsy. Participants will receive light therapy three times a week for about 15 weeks while being monitored.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Active photobiomodulation sessionsActive Control1 Intervention
Group II: Control photobiomodulation sessionsPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cynthia Kerson

Lead Sponsor

Citations

Lights for epilepsy: can photobiomodulation reduce seizures ...

We suggest that photobiomodulation can form an effective, safe, non-pharmacological, and non-invasive treatment option for patients with epilepsy.

Infrared Photobiomodulation in Humans With Epilepsy

In animals, this treatment has shown promise as a possible way to reduce seizures, but it has not been tested in humans for this. The investigators are ...

Effects of Chronic Photobiomodulation with Transcranial Near ...

Our data show that PBM treatment significantly reduced the seizure frequency in rats with pilocarpine-induced seizures. Additionally, ...

Mitochondrial Photobiomodulation as a Neurotherapeutic ...

Photobiomodulation attenuated the mean seizure score and reduced the incidence of status epilepticus and mortality. Vogel et al. (29), Wistar rats, ...

NCT07509177 | An Examination of Whether Infrared Light ...

An Examination of Whether Infrared Light Therapy Can Reduce Stress in People With Epilepsy (PBM Rise). ClinicalTrials.gov ID NCT07509177. Sponsor Cynthia ...

Infrared Photobiomodulation for Epilepsy

Research has shown that infrared light therapy is generally safe and well-tolerated. Studies indicate that this treatment does not cause significant side ...