Infrared Photobiomodulation in Humans With Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-25

Study Completion Date

2027-09-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Drug-resistant epilepsy represents roughly 40% of people with epilepsy. It is very challenging to stop seizures in this condition, and the treatment options are limited. This study aims to investigate a new treatment that involves using infra-red light. 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 interested to know if it can reduce seizures, and how comfortable it is to be treated with this therapy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Green Light Exposure on Epileptic Spikes in Patients With Refractory Epilepsy

NCT03857074

Epilepsy Epilepsy Intractable

UNKNOWN NA

Optimization of Deep Brain Stimulation Parameters in Patients With Medically Refractory Epilepsy

NCT05493722

Refractory Epilepsy Deep Brain Stimulation

RECRUITING EARLY_PHASE1

Cerebral Oxygen Saturation and Cytochrome Oxidase REDOX State in Children With Epilepsy: A Pilot Study

NCT03054961

Epilepsies, Partial

COMPLETED

Thalamus Seizure Detection With a Deep Brain Stimulator System

NCT06700356

Epilepsy; Seizure

RECRUITING NA

A Deep Brain Stimulation System in Epilepsy: Tracking Neural Excitability

NCT03465163

Epilepsy Nodular Heterotopia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Epilepsy affects 12 out of every 1000 people in the United States (1.2%). Of those, roughly 40% have drug-resistant epilepsy, meaning seizures do not stop despite good doses given with two different anti-seizure medications. Patients in this situation have several options (1) try additional medications (2) consider surgery to remove the part of the brain causing seizures, if possible (3) consider neuromodulation devices that change the brain activity using electricity in the brain (also a surgery) (4) try special diets such as the ketogenic diet which changes the fuel used by the brain by only eating certain foods. Despite these options, a large number of patients continue to have seizures. There is a great need for new treatments for drug resistant epilepsy.

The main purpose of this study is to determine if a new treatment is safe and well tolerated. Everyone in this study will receive the Red Light Therapy Hat which is investigational and is not approved by the FDA. The investigators do not know all the ways that this study treatment may affect people. This study is intended to hopefully help the participants, and the investigators hope the information from this study will help us develop a better treatment for drug resistant epilepsy in the future.

This particular investigational technology has been approved by the FDA for use in other diseases or conditions, but the investigators do not yet know if it is useful or safe as a treatment for drug resistant epilepsy.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Drug Resistant Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

photobiomodulation

participants will use photobiomodulation daily for 6 months

Group Type EXPERIMENTAL

photobiomodulation

Intervention Type DEVICE

a hat with infrared lights will be worn for 30 minutes daily for 6 months

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

photobiomodulation

a hat with infrared lights will be worn for 30 minutes daily for 6 months

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Drug resistant epilepsy
* Age 18 or older
* Average seizure rate of at least 2 seizures per month
* Accurate seizure diary with at least 3 months recorded

Exclusion Criteria

* Implanted intracranial neurostimulation device (DBS or RNS)
* Intracranial shunt
* Skin photosensitivity
* Cancer on scalp
* Taking any medication that can cause photosensitivity

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No