Infrared Photobiomodulation in Humans With Epilepsy

NCT07145489 | Recruiting

• 1 other identifier: 2025P000606
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Drug Resistant Epilepsy

Keywords

epilepsy; photobiomodulation; seizure

Outcome Measures

Primary Outcomes (2)

• seizure rate reduction

  fraction of seizures reduced by therapy assessed by individual baseline rate

  6 months

• tolerability of daily photobiomodulation

  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?

  6 months

Secondary Outcomes (1)

• seizure duration

  6 months

Study Arms (1)

photobiomodulation

EXPERIMENTAL

participants will use photobiomodulation daily for 6 months

Device: photobiomodulation

Interventions

photobiomodulation DEVICE

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

photobiomodulation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

BIDMC

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy; Seizures

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Daniel Goldenholz, MD PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Goldenholz, MD, PhD

CONTACT

617-632-8930; daniel.goldenholz@bidmc.harvard.edu

Daniel Goldenholz, MD PhD

CONTACT

617-632-8930; daniel.goldenholz@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 28, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 25, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: 1 year after the completion of enrollment, and for at least 4 years thereafter
• Access Criteria: It will be made publicly accessible to anyone via public repository and via journal publication

Locations

US (1)