What this study is
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.
What's being tested
- photobiomodulation
Intervention · DEVICE
a hat with infrared lights will be worn for 30 minutes daily for 6 months
Study details
- Official title
- An Open Label Pilot Study of Infrared Photobiomodulation in Humans With Epilepsy
- Sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Drug Resistant Epilepsy
- Enrolling
- 13 people
- Starts
- 2025-11-25
- Est. completion
- 2027-09-25
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join if
- Implanted intracranial neurostimulation device (DBS or RNS)
- Intracranial shunt
- Skin photosensitivity
- Cancer on scalp
- Taking any medication that can cause photosensitivity
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openBIDMC
Boston, Massachusetts, United States
- Daniel Goldenholz, MD PhD · Contact617-632-8930daniel.goldenholz@bidmc.harvard.edu
- Daniel Goldenholz, MD PhD · Principal investigator
Recruiting
Study team
Sponsor
Beth Israel Deaconess Medical Center
Study ID 2025P000606
Principal investigator
Daniel Goldenholz, MD PhD
Beth Israel Deaconess Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.