Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07145489

Infrared Photobiomodulation in Humans With Epilepsy

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BIDMC

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Daniel Goldenholz, MD PhD

CONTACT

[email protected]

617-632-8930

Daniel Goldenholz, MD PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Photobiomodulation

Device

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

Primary outcomes

  1. seizure rate reduction

    Time frame: 6 months

    fraction of seizures reduced by therapy assessed by individual baseline rate

  2. tolerability of daily photobiomodulation

    Time frame: 6 months

    Do participants find it reasonable to use the therapy daily or do they request exiting from the study? Do participants report significant side effects as reported by weekly check-ins that make the therapy uncomfortable or intolerable?

Secondary outcomes

  1. seizure duration

    Time frame: 6 months

    fraction of seizure duration reduction assessed by baseline seizure durations

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Goldenholz, MD PhD

CONTACT

[email protected]

617-632-8930

Daniel Goldenholz, MD, PhD

CONTACT

[email protected]

617-632-8930

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

An Open Label Pilot Study of Infrared Photobiomodulation in Humans With Epilepsy

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 28, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.